Chronic Heart Failure (CHF)
Conditions
Keywords
low-interventional observational study,, CHF,, heart failure,, primary care,, ESC guidelines,, Europe,, NT-proBNP,, reduced ventricular ejection fraction (EF),
Brief summary
This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.
Detailed description
In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF \< or = 40%) and NT-proBNP level \> or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..
Interventions
PROCEDUREStandard care
Patients will receive the treatment that their primary care physician has decided to prescribe for their disease
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide written informed consent and accept study procedures and time schedule. * Age ≥ 18 years. * Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history). * Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.
Exclusion criteria
* Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. * Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study. * Cancer or other significant co-morbidities implying that the patient's condition is unstable. * Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR \< 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months. * Patients who are primarily managed and regularly followed-up by a cardiologist for their HF * Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Baseline (Visit 1) | Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. |
| Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Month 6 | Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | 6 months (Visit 2) | Use of concomitant compounds were collected at 6 months (Visit 2) |
| Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | 6 months | For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters. |
| Number of Patients With Different NT-proBNP Level Categories | One measurement in all consecutive patients at baseline (Visit 1) | NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \> 1200 pg/ml). |
| Percentages of Clinically Stable Patients | Baseline (Visit 1) | Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion. |
| Number of Patients by Cardiologist Prescription Practice Per Country/Region | 6 months | The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline. |
| Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | 10 months | At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline. |
| Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3) | Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF). |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3) | The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure. |
| Number of Patients in Different Living Conditions | Baseline (Visit 1) | Living conditions were collected at Baseline (Visit 1). |
| Number of Patients in Different Employment Status | Baseline (Visit 1) | Employment status was collected at Baseline (Visit 1). |
| Number of Patients With Smoking Status | Baseline (Visit 1) | Smoking status was collected at baseline (visit 1). |
| Duration of Heart Failure | Baseline (Visit 1) | The duration of Heart Failure was collected at Baseline (Visit 1). |
| Number of Patients With Health Insurance Status | Baseline (Visit 1) | Health insurance status was collected at Baseline (Visit 1). |
| Number of Patients at Different Educational Level | Baseline (Visit 1) | Educational level was collected at Baseline (Visit 1). |
| Number of Patients Per Primary Etiology of Heart Failure | Baseline (Visit 1) | The primary etiology of Heart Failure was collected at Baseline (Visit 1). |
| Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Baseline (Visit 1), 6 months, 10 months | HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline. |
| Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Baseline (Visit 1) | Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1) |
| Mean Dose of Previously Taken and Current Use of Concomitant Medications | Baseline (Visit 1), 6 months, 10 months | Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline |
| Number of Heart Failure (HF) Treatment Combinations | Baseline (Visit 1) | The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1). |
| Duration of Treatment With Device Type | Baseline (Visit 1) | The duration of treatment with device type was collected at baseline (Visit 1) |
| Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds | Baseline (Visit 1) | Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected |
| Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region | Baseline (Visit 1) | For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented. |
| Number of Patients From Different Geographical Regions | Baseline (visit 1) | Geographic regions were collected at Baseline (Visit 1). |
| Number of Patients With Current Use of Concomitant Compound | Baseline (Visit 1) | Use of concomitant compounds were collected at baseline (Visit 1) |
Countries
Belgium, Croatia, Cyprus, Denmark, Estonia, France, Hungary, Israel, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Russia, Slovenia, Spain
Participant flow
Recruitment details
The enrolled set consisted of 1415 patients. 861 patients were referred to a cardiologist within this study and Based on findings from the interim-analysis, Novartis decided to terminate the study prematurely in March 2018.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable an with NT-proBNP levels \> 600 pg/ml were referred to a cardiologist for evaluation and were in the follow-up set. | 1,415 |
| Total | 1,415 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrolled Set | Patients not suitable for follow-up. | 551 |
| Follow-Up Set | Adverse Event | 3 |
| Follow-Up Set | Death | 27 |
| Follow-Up Set | Lost to Follow-up | 7 |
| Follow-Up Set | Physician Decision | 6 |
| Follow-Up Set | Relocation | 2 |
| Follow-Up Set | Study Terminated By Sponsor | 131 |
| Follow-Up Set | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Enrolled Patients |
|---|---|
| Age, Continuous | 69.8 Years STANDARD_DEVIATION 11.6 |
| Age, Customized <65 years | 482 Participants |
| Age, Customized ≥65 years to <75 years | 408 Participants |
| Age, Customized ≥75 years to <85 years | 401 Participants |
| Age, Customized ≥85 years | 124 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 126 Participants |
| Race (NIH/OMB) White | 1282 Participants |
| Sex: Female, Male Female | 436 Participants |
| Sex: Female, Male Male | 979 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 32 / 1,415 | 30 / 861 |
| other Total, other adverse events | 187 / 1,415 | 181 / 861 |
| serious Total, serious adverse events | 117 / 1,415 | 114 / 861 |
Outcome results
Primary
Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose
Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
Time frame: Month 6
Population: Follow-Up set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Adherence at V2, not adherent at V1 for drug type | 3.3 Percentage of Patients |
| Enrolled Set | Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Adherence at V2, not adherent at V1:drug type/dose | 0.8 Percentage of Patients |
| Enrolled Set | Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Adherence at V2 and V1 for drug type | 79.2 Percentage of Patients |
| Enrolled Set | Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Adherence at Visit 1 for drug type & dose | 86.7 Percentage of Patients |
Primary
Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)
Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
Time frame: Baseline (Visit 1)
Population: Enrolled and Follow-up Set included. Due to missing left ventricular ejection fraction (LVEF) values, some patients could not be classified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Level 1: Drug Type : Adherent | 110 Participants |
| Enrolled Set | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Level 1: Drug type : Not Adherent | 802 Participants |
| Enrolled Set | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Patients missing LVEF values | 503 Participants |
| Follow-Up Set | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Level 1: Drug Type : Adherent | 59 Participants |
| Follow-Up Set | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Level 1: Drug type : Not Adherent | 523 Participants |
| Follow-Up Set | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Patients missing LVEF values | 279 Participants |
Secondary
Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)
Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).
Time frame: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)
Population: Enrolled Set for Visit 1 (Baseline) and Follow-Up Set (Visit 2 and 3) for those clinically stable patients who entered the prospective period of the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enrolled Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ5D Utility index - Visit 1 | 0.81 Scores on a scale |
| Enrolled Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ-5D Visual Analog Scale (VAS) - Visit 1 | 60 Scores on a scale |
| Follow-Up Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ5D Utility index - Visit 1 | 0.79 Scores on a scale |
| Follow-Up Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ5D Utility index - Visit 2 | 0.80 Scores on a scale |
| Follow-Up Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ5D Utility index absolute change (V2-V1) | 0.00 Scores on a scale |
| Follow-Up Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ5D Utility index - Visit 3 | 0.78 Scores on a scale |
| Follow-Up Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ5D Utility index absolute change (V3-V1) | 0.00 Scores on a scale |
| Follow-Up Set | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | EQ-5D Visual Analog Scale (VAS) - Visit 1 | 60 Scores on a scale |
Secondary
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)
The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.
Time frame: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)
Population: Enrolled Set for Visit 1 (Baseline) and Follow-Up Set (Visit 2 and 3) for those clinically stable patients who entered the prospective period of the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enrolled Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Overall Summary Score - Visit 1 | 70.1 Utility Index Score |
| Enrolled Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Clinical Summary Score - Visit 1 | 72.1 Utility Index Score |
| Enrolled Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Total Symptom Score - Visit 1 | 77.1 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Overall Summary Score - Visit 1 | 66.1 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Overall Summary Score absolute change (V2-V1) | 0.0 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Overall Summary Score - Visit 3 | 66.7 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Overall Summary Score absolute change (V3-V1) | 0.5 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Clinical Summary Score - Visit 2 | 68.8 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Clinical Summary Score abs. change (V2-V1) | 0.00 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Clinical Summary Score - Visit 3 | 68.8 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Summary Score absolute change (V3-V1) | 0.0 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Total Symptom Score - Visit 1 | 74.0 Utility Index Score |
| Follow-Up Set | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | KCCQ Clinical Summary Score - Visit 1 | 68.8 Utility Index Score |
Secondary
Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline
At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline.
Time frame: 10 months
Population: Follow-Up Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrolled Set | Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | NT-proBNP [pg/ml] at Visit 1 (Baseline) | 2753 pg/mL | Standard Deviation 2530 |
| Enrolled Set | Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | NT-proBNP [pg/ml] at Visit 3 (10 months) | 2245 pg/mL | Standard Deviation 2303 |
| Enrolled Set | Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | Absolute change in NT-proBNP (V3-V1) | -504 pg/mL | Standard Deviation 2607 |
Secondary
Duration of Heart Failure
The duration of Heart Failure was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Duration of Heart Failure | >3 years | 896 Participants |
| Enrolled Set | Duration of Heart Failure | ≤3 years | 517 Participants |
| Follow-Up Set | Duration of Heart Failure | >3 years | 549 Participants |
| Follow-Up Set | Duration of Heart Failure | ≤3 years | 312 Participants |
Secondary
Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds
Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected
Time frame: Baseline (Visit 1)
Population: Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds | Drugs for acid related disorders-≤1 and >3 years | 0.31 Percentage of participants |
| Enrolled Set | Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds | Antithrombotic agents -≤1 and >3 years | 0.65 Percentage of participants |
| Enrolled Set | Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds | Lipid modifying agents -≤1 and >3 years | 0.57 Percentage of participants |
Secondary
Duration of Treatment With Device Type
The duration of treatment with device type was collected at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Population: Follow-Up Set (Data was not collected for this endpoint)
Secondary
Mean Dose of Previously Taken and Current Use of Concomitant Medications
Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline
Time frame: Baseline (Visit 1), 6 months, 10 months
Population: Enrolled Set and Follow-Up Set (Mean dose of concomitant medications was not collected/provided and could not be alternately computed based upon the information listed).
Secondary
Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2
Use of concomitant compounds were collected at 6 months (Visit 2)
Time frame: 6 months (Visit 2)
Population: Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Mineral supplements | 65 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Calcium channel blockers | 35 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Diuretics - without mineral corticoid antagonists | 581 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Beta blocking agents | 533 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Agents acting on the renin-angiotensin system | 476 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Diuretics - mineral corticoid antagonists | 423 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Antithrombotic agents | 221 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Cardiac therapy | 238 Participants |
| Enrolled Set | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Lipid modifying agents | 92 Participants |
Secondary
Number of Heart Failure (HF) Treatment Combinations
The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Follow-Up Set: Patients who were considered clinically stable and had NT-proBNP levels \> 600 pg/ml who were referred to a cardiologist at Baseline (Visit 1) for evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | One ACEi or one ARB and one beta-blocker(V1) | 178 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one beta-blocker and one MRA(V1) | 166 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one ACEi or one ARB and one MRA(V1) | 165 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V1) | 82 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one beta-blocker and ARNi(V1) | 13 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one MRA and ARNi(V1) | 20 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one MRA and one beta-blocker and ARNi(V1) | 9 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | One ACEi or one ARB and one beta-blocker(V2) | 156 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one beta-blocker and one MRA(V2) | 160 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one ACEi or one ARB and one MRA(V2) | 177 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V2) | 91 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one beta-blocker and ARNi(V2) | 17 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one MRA and ARNi(V2) | 23 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one MRA and one beta-blocker and ARNi(V2) | 10 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | One ACEi or one ARB and one beta-blocker(V3) | 120 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one beta-blocker and one MRA(V3) | 130 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one ACEi or one ARB and one MRA(V3) | 143 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V3) | 77 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one beta-blocker and ARNi(V3) | 11 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one MRA and ARNi(V3) | 17 Number of Participants |
| Enrolled Set | Number of Heart Failure (HF) Treatment Combinations | Exactly one MRA and one beta-blocker and ARNi(V3) | 6 Number of Participants |
Secondary
Number of Patients at Different Educational Level
Educational level was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients at Different Educational Level | Secondary Education | 730 Number of Participants |
| Enrolled Set | Number of Patients at Different Educational Level | None | 30 Number of Participants |
| Enrolled Set | Number of Patients at Different Educational Level | University | 257 Number of Participants |
| Enrolled Set | Number of Patients at Different Educational Level | Missing | 2 Number of Participants |
| Enrolled Set | Number of Patients at Different Educational Level | Primary Education | 396 Number of Participants |
| Follow-Up Set | Number of Patients at Different Educational Level | Missing | 2 Number of Participants |
| Follow-Up Set | Number of Patients at Different Educational Level | Primary Education | 248 Number of Participants |
| Follow-Up Set | Number of Patients at Different Educational Level | Secondary Education | 421 Number of Participants |
| Follow-Up Set | Number of Patients at Different Educational Level | University | 173 Number of Participants |
| Follow-Up Set | Number of Patients at Different Educational Level | None | 17 Number of Participants |
Secondary
Number of Patients by Cardiologist Prescription Practice Per Country/Region
The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline.
Time frame: 6 months
Population: Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients by Cardiologist Prescription Practice Per Country/Region | Western EU | 198 Number of Participants |
| Enrolled Set | Number of Patients by Cardiologist Prescription Practice Per Country/Region | Eastern EU | 525 Number of Participants |
Secondary
Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region
For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented.
Time frame: Baseline (Visit 1)
Population: Follow-Up Set (Data was not collected for this endpoint.)
Secondary
Number of Patients From Different Geographical Regions
Geographic regions were collected at Baseline (Visit 1).
Time frame: Baseline (visit 1)
Population: Enrolled Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients From Different Geographical Regions | RUS | 226 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | BEL | 201 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | HRV | 169 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | SVN | 122 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | POL | 120 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | LTU | 103 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | HUN | 94 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | FRA | 89 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | ESP | 76 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | NOR | 58 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | CYP | 36 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | LVA | 34 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | MLT | 26 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | EST | 18 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | DNK | 19 Number of Participants |
| Enrolled Set | Number of Patients From Different Geographical Regions | PRT | 13 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | PRT | 6 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | RUS | 173 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | ESP | 30 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | BEL | 114 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | MLT | 17 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | HRV | 95 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | NOR | 33 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | SVN | 72 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | DNK | 4 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | POL | 74 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | CYP | 20 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | LTU | 65 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | EST | 16 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | HUN | 58 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | LVA | 22 Number of Participants |
| Follow-Up Set | Number of Patients From Different Geographical Regions | FRA | 54 Number of Participants |
Secondary
Number of Patients in Different Employment Status
Employment status was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients in Different Employment Status | Student | 0 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Employed (part-time) | 49 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Employed (full-time) | 144 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Homemaker | 26 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Retired | 1034 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Unemployed | 85 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Sustained Sick Leave | 73 Number of Participants |
| Enrolled Set | Number of Patients in Different Employment Status | Missing | 4 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Missing | 4 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Student | 0 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Retired | 680 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Employed (part-time) | 28 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Sustained Sick Leave | 40 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Employed (full-time) | 51 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Unemployed | 43 Number of Participants |
| Follow-Up Set | Number of Patients in Different Employment Status | Homemaker | 15 Number of Participants |
Secondary
Number of Patients in Different Living Conditions
Living conditions were collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients in Different Living Conditions | Living with spouse or significant other | 817 Number of Participants |
| Enrolled Set | Number of Patients in Different Living Conditions | Living in a long term care facility | 20 Number of Participants |
| Enrolled Set | Number of Patients in Different Living Conditions | Living in residence with other family member | 264 Number of Participants |
| Enrolled Set | Number of Patients in Different Living Conditions | Transient housing | 1 Number of Participants |
| Enrolled Set | Number of Patients in Different Living Conditions | Living independently in household (alone) | 313 Number of Participants |
| Follow-Up Set | Number of Patients in Different Living Conditions | Transient housing | 1 Number of Participants |
| Follow-Up Set | Number of Patients in Different Living Conditions | Living independently in household (alone) | 204 Number of Participants |
| Follow-Up Set | Number of Patients in Different Living Conditions | Living with spouse or significant other | 481 Number of Participants |
| Follow-Up Set | Number of Patients in Different Living Conditions | Living in residence with other family member | 159 Number of Participants |
| Follow-Up Set | Number of Patients in Different Living Conditions | Living in a long term care facility | 16 Number of Participants |
Secondary
Number of Patients Per Primary Etiology of Heart Failure
The primary etiology of Heart Failure was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients Per Primary Etiology of Heart Failure | Primary Etiology- Ischemic | 860 Number of Participants |
| Enrolled Set | Number of Patients Per Primary Etiology of Heart Failure | Primary Etiology-Non-Ischemic | 553 Number of Participants |
| Follow-Up Set | Number of Patients Per Primary Etiology of Heart Failure | Primary Etiology- Ischemic | 541 Number of Participants |
| Follow-Up Set | Number of Patients Per Primary Etiology of Heart Failure | Primary Etiology-Non-Ischemic | 320 Number of Participants |
Secondary
Number of Patients With Current Use of Concomitant Compound
Use of concomitant compounds were collected at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Beta blocking agents | 981 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Cardiac therapy | 365 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Diuretics - mineral corticoid antagonists | 664 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Lipid modifying agents | 163 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Agents acting on the renin-angiotensin system | 834 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Mineral supplements | 110 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Antithrombotic agents | 401 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Calcium channel blockers | 65 Participants |
| Enrolled Set | Number of Patients With Current Use of Concomitant Compound | Diuretics - without mineral corticoid antagonists | 934 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Calcium channel blockers | 39 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Diuretics - without mineral corticoid antagonists | 625 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Beta blocking agents | 602 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Agents acting on the renin-angiotensin system | 491 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Diuretics - mineral corticoid antagonists | 416 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Antithrombotic agents | 256 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Cardiac therapy | 238 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Lipid modifying agents | 96 Participants |
| Follow-Up Set | Number of Patients With Current Use of Concomitant Compound | Mineral supplements | 69 Participants |
Secondary
Number of Patients With Different NT-proBNP Level Categories
NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \> 1200 pg/ml).
Time frame: One measurement in all consecutive patients at baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 600 pg/ml to <800 pg/ml | 135 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1400 pg/ml to <1600 pg/ml | 32 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1000 pg/ml to <1200 pg/ml | 80 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1600 pg/ml to <1800 pg/ml | 33 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 800 pg/ml to <1000 pg/ml | 97 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1800 pg/ml to <2000 pg/ml | 30 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1200 pg/ml to <1400 pg/ml | 48 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 2000 pg/ml | 465 Participants |
| Enrolled Set | Number of Patients With Different NT-proBNP Level Categories | <600 pg/ml | 495 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 2000 pg/ml | 431 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | <600 pg/ml | 0 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 600 pg/ml to <800 pg/ml | 130 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 800 pg/ml to <1000 pg/ml | 93 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1000 pg/ml to <1200 pg/ml | 75 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1200 pg/ml to <1400 pg/ml | 46 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1400 pg/ml to <1600 pg/ml | 24 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1600 pg/ml to <1800 pg/ml | 33 Participants |
| Follow-Up Set | Number of Patients With Different NT-proBNP Level Categories | ≥ 1800 pg/ml to <2000 pg/ml | 29 Participants |
Secondary
Number of Patients With Health Insurance Status
Health insurance status was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients With Health Insurance Status | Statutory Health Insurance | 1168 Number of Participants |
| Enrolled Set | Number of Patients With Health Insurance Status | Private Health Insurance | 29 Number of Participants |
| Enrolled Set | Number of Patients With Health Insurance Status | Combined statutory and private health insurance | 171 Number of Participants |
| Enrolled Set | Number of Patients With Health Insurance Status | None | 47 Number of Participants |
| Follow-Up Set | Number of Patients With Health Insurance Status | None | 29 Number of Participants |
| Follow-Up Set | Number of Patients With Health Insurance Status | Statutory Health Insurance | 712 Number of Participants |
| Follow-Up Set | Number of Patients With Health Insurance Status | Combined statutory and private health insurance | 98 Number of Participants |
| Follow-Up Set | Number of Patients With Health Insurance Status | Private Health Insurance | 22 Number of Participants |
Secondary
Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study
HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.
Time frame: Baseline (Visit 1), 6 months, 10 months
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Visit 1- Up to Baseline | 383 Number of Participants |
| Enrolled Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Visit 2-6 months | 0 Number of Participants |
| Enrolled Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Visit 3-10 months | 0 Number of Participants |
| Enrolled Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Missing | 0 Number of Participants |
| Follow-Up Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Missing | 6 Number of Participants |
| Follow-Up Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Visit 1- Up to Baseline | 262 Number of Participants |
| Follow-Up Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Visit 3-10 months | 22 Number of Participants |
| Follow-Up Set | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | Visit 2-6 months | 18 Number of Participants |
Secondary
Number of Patients With Smoking Status
Smoking status was collected at baseline (visit 1).
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Number of Patients With Smoking Status | Never | 779 Number of Participants |
| Enrolled Set | Number of Patients With Smoking Status | Current | 205 Number of Participants |
| Enrolled Set | Number of Patients With Smoking Status | Former | 427 Number of Participants |
| Enrolled Set | Number of Patients With Smoking Status | Missing | 4 Number of Participants |
| Follow-Up Set | Number of Patients With Smoking Status | Missing | 2 Number of Participants |
| Follow-Up Set | Number of Patients With Smoking Status | Never | 500 Number of Participants |
| Follow-Up Set | Number of Patients With Smoking Status | Former | 246 Number of Participants |
| Follow-Up Set | Number of Patients With Smoking Status | Current | 113 Number of Participants |
Secondary
Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities
Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Population: Enrolled Set and Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Hypertension | 74.2 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Dyslipidemia | 61.6 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | History of myocardial infarction | 43.9 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Atrial fibrillation | 40.8 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Obesity | 36.1 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Stable angina pectoris | 31.4 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Diabetes mellitus type 2 | 29.9 Percentage of Participants |
| Enrolled Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Other Comorbidities | 13.0 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Other Comorbidities | 14.0 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Hypertension | 75.8 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Obesity | 30.8 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Dyslipidemia | 58.8 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Diabetes mellitus type 2 | 31.5 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | History of myocardial infarction | 44.4 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Stable angina pectoris | 33.8 Percentage of Participants |
| Follow-Up Set | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Atrial fibrillation | 52.3 Percentage of Participants |
Secondary
Percentages of Clinically Stable Patients
Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion.
Time frame: Baseline (Visit 1)
Population: Enrolled Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Percentages of Clinically Stable Patients | Patients clinically stable | 96.9 Percentage of Participants |
| Enrolled Set | Percentages of Clinically Stable Patients | Patients not clinically stable | 3.1 Percentage of Participants |
| Enrolled Set | Percentages of Clinically Stable Patients | Patients suitable for prospective period of study | 63.2 Percentage of Participants |
| Enrolled Set | Percentages of Clinically Stable Patients | Patients not suitable for prospective period | 36.8 Percentage of Participants |
Secondary
Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics
For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters.
Time frame: 6 months
Population: Follow-Up Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled Set | Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | Cardiologist's advice-No change | 45.1 Percentage of Patients |
| Enrolled Set | Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | Cardiologist's advice-Treatment intensification | 30.7 Percentage of Patients |
| Enrolled Set | Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | Cardiologist's advice-Treatment reduction | 6.3 Percentage of Patients |
| Enrolled Set | Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | Cardiologist's advice-Treatment adaption | 17.9 Percentage of Patients |