Heart Failure
Conditions
Keywords
Up-titration, Nursing or Nurse, Heart Failure
Brief summary
Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New (de novo) HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation
Detailed description
No apply
Interventions
OTHERHeart Failure (HF) nurse up-titration
Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure De Novo patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines with cardiologist prescription and support.
OTHERHeart Failure (HF) cardiologist up-titration
Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure De Novo patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines. Drugs are prescribed and titrated by the cardiologist.
Sponsors
Carlos III Health Institute
Basque Health Service
Hospital Galdakao-Usansolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient with de novo heart Failure and LVEF \<= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent.
Exclusion criteria
* Contraindications for BB. * Living in a nursing home. * Life expectancy \< 6 months. * Unable to self-care or mental disease without caregiver. * Unable to weight * Without phone * Unable to go to clinic visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BB % Relative Dose (Mean) With Regard to Target Dose | 4 months | BB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month) | 4 months | Number of participants with Potassium≥ 5.5 meq/l during the titration process (from baseline to 4 month) that could be associated to this titration process |
| Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month) | 4 months | Description: Number of participants with symptomatic hypotension during the titration process (from baseline to 4 month) that could be associated to this titration process. Symptomatic hypotension defined as symptoms such as dizziness or light headedness, associated to hypotension |
| Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month) | 4 months | Number of participants with Heart Rate (HR) \< 50 beats per minute during the titration process (from baseline to 4 month) , which could be associated to the titration process. (with or without symptoms) |
| Number of Patients With Atrio Ventricular (AV) Block Due to Titration | 4 months | Number of patients with AV Block during the titration process, associated to the BB titration |
| Number of Patients With Worsening of Heart Failure Signs and Symptoms | 4 months | Number of patients with worsening of heart failure signs and symptoms during the titration process ( from baseline to 4 month) which could be associated to the titration process. |
| Number of Patients With Admissions Due to Titration | 4 months | Number of patients with admissions due to titration ( not due to other causes) |
| Number of Patients: Mortality Due to Titration | 4 months | Number of patients: Mortality due to titration ( not due to other causes) |
| Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | 4 months | number of paticipants with drug Stop ( withdrawal) that occur during the titration process that could be due to an adverse event. ( it can be not only due to an adverse event but because there is no need of this drug or its substitution for another kind of drug) |
| Change in % Left Ventricular Ejection Fraction | 6 months | Change in % Left Ventricular Ejection Fraction (difference of change from baseline to 6 months between groups) Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. |
| Number of Participants With Worsening Renal Function (From Baseline to 4th Month) | 4 months | Number of participants with worsening renal function during the titration process (from baseline to 4 month) that could be associated to the titration process (Creatinine increase \>50% baseline creatinine or creatinine\>3mg/dl, or Estimated Glomerular Filtration\<25 ml/min/1.73 m2) |
| ACEI % Relative Dose (Mean) With Regard to Target Dose | 4 Months | ACEI mean Relative dose is the mean dose of ACEI achieved 4 months after starting titration, relative to target dose (%) described in European guidelines |
| N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP) | 6 months | Nt-proBNP (N-terminal pro-B type natriuretic peptide) Improvement (Decrease) difference of change from baseline to 6 months between groups, mean (SD) |
| 6 Minute Walking Test | 6 months | 6 minute walking test improvement ( change) meters.Improvement (difference of change from baseline to 6 months between groups Six minute walking test. Measurement of exercise capacity is an integral element in assessment of patients with cardiopulmonary disease. It provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions. The six-minute walk test (6MWT) measures the distance (meters) an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. |
| Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | 6 months | Number of participants class I-IV New York Heart Association (NYHA) functional classification, based on severity of symptoms and physical activity: NYHA I (better): No limitation of physical activity; NYHA II: Slight limitation of ordinary physical activity, breathlessness; NYHA III: marked limitation of physical activity. Comfortable at rest, but less than ordinary activity results in undue breathlessness, fatigue or palpitations; NYHA IV ( worse): unable to carry on any physical activity without discomfort.Symptoms at rest can be present. If any physical activity is undertaken discomfort is increased. |
| Quality of Life: MLWHFQ | 6 months | Quality of Life, measured by Minnesota Living with Heart Failure Questionnaire. Improvement (change) from baseline to 6 months. Minnesota Living With Heart Failure Questionnaire (MLWHFQ). The content of this questionnaire was selected to be representative of the ways heart failure and treatments can affect the key physical, emotional, social and mental dimensions of quality of life of patients with heart failure. It consist of 21-items with score 0-5. Final evaluation moves from 0 (none) to 105 (very much); a lower score means better quality of life. |
| European Quality of Life Scale: EuroQol- 5 Dimension Index | 6 months | European Quality of Life Scale: EuroQol- 5 Dimension index (Range: 1 full health-0 death). It measures health status self-reported by the patient. It has 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels: 1 no problem; 2 some or moderate problems; 3 extreme problems. The EuroQol Research Foundation converts this information into a single summary index, by applying a formula that attaches specific country values (called weights) to each of the levels in each dimension. The index is calculated by subtracting the mentioned weights from 1, the value for full health. We measured the EuroQol-5D index improvement (change) from baseline to 6 months. More information in: EQ-5D-3L-User-Guide\_version-6.0 (1).pdf |
| Number of Patients With Admissions Due to Heart Failure (HF) | 6 months | Number of patients with hospital admissions due to Heart Failure. From Baseline to 6 months |
| ARB % Relative Dose (Mean) With Regard to Target Dose | 4 months | ARB, angiotensin II receptor blockers, mean relative dose ( % to target dose). Target dose is described in European guidelines. Measured at 4 months after starting titration. |
| MRA % Relative Dose (Mean) With Regard to Target Dose | 4 months | MRA % relative dose (mean) is the mean dose achieved 4 months after starting titration with regard to target dose (%) described in european guidelines |
| Number of Patients With Deaths | 6 months | Number of Patients with deaths due to Cardiovascular and non cardiovascular causes |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Heart Failure (HF) Cardiologist Up-titration Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure De Novo Left Ventricular Ejection Fraction≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines | 156 |
| HF Nurse Up-titration Patients, following a protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, . Protocol based on 2012 ESC HF guidelines. | 164 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 4 Months Evaluation | Death | 2 | 3 |
| 4 Months Evaluation | HF Unit not active in summer | 1 | 0 |
| 4 Months Evaluation | Lost to Follow-up | 3 | 3 |
| 4 Months Evaluation | Physician Decision | 3 | 0 |
| 4 Months Evaluation | reasons not due to titration | 4 | 1 |
| 4 Months Evaluation | Withdrawal by Subject | 2 | 3 |
| 4 Months Evaluation | Working or living abroad | 5 | 1 |
| 6 Months Evaluation | Death | 1 | 1 |
| 6 Months Evaluation | Lost to Follow-up | 1 | 1 |
| 6 Months Evaluation | reasons not due to titration | 0 | 1 |
| 6 Months Evaluation | Working or living abroad | 6 | 4 |
Baseline characteristics
| Characteristic | Heart Failure (HF) Cardiologist Up-titration | HF Nurse Up-titration | Total |
|---|---|---|---|
| 6 minute walking test | 370 meters STANDARD_DEVIATION 108 | 361 meters STANDARD_DEVIATION 102 | 366 meters STANDARD_DEVIATION 105 |
| ACEI mean relative dose | 40.13 % to target dose STANDARD_DEVIATION 25.38 | 45.92 % to target dose STANDARD_DEVIATION 30.06 | 43.04 % to target dose STANDARD_DEVIATION 27.81 |
| Age, Continuous | 60.64 years STANDARD_DEVIATION 12.25 | 61.88 years STANDARD_DEVIATION 12.14 | 61.28 years STANDARD_DEVIATION 12.19 |
| Angiotensin II Receptor Blockers (ARB) mean relative dose | 43.20 % to target dose STANDARD_DEVIATION 20.63 | 29.15 % to target dose STANDARD_DEVIATION 14.99 | 33.84 % to target dose STANDARD_DEVIATION 17.95 |
| betablocker mean relative dose | 34.80 % to target dose STANDARD_DEVIATION 20.6 | 34.81 % to target dose STANDARD_DEVIATION 18.16 | 34.80 % to target dose STANDARD_DEVIATION 19.38 |
| European Quality of Life Scale: EuroQol- 5 Dimension index | 0.75 score on a scale STANDARD_DEVIATION 0.24 | 0.73 score on a scale STANDARD_DEVIATION 0.23 | 0.74 score on a scale STANDARD_DEVIATION 0.23 |
| left ventricular ejection fraction % | 27.45 %of blood leaving the heart /beat STANDARD_DEVIATION 7.25 | 27.95 %of blood leaving the heart /beat STANDARD_DEVIATION 6.69 | 27.71 %of blood leaving the heart /beat STANDARD_DEVIATION 6.97 |
| Minnesota living with heart failure questionnaire | 45.71 units on a scale STANDARD_DEVIATION 22.21 | 50.8 units on a scale STANDARD_DEVIATION 22.61 | 48.31 units on a scale STANDARD_DEVIATION 22.52 |
| MRA mean relative dose | 63.18 % to target dose STANDARD_DEVIATION 33 | 61.4 % to target dose STANDARD_DEVIATION 33.52 | 62.30 % to target dose STANDARD_DEVIATION 33.21 |
| Nt-proBNP | 3001 pg/ml STANDARD_DEVIATION 4041 | 3425 pg/ml STANDARD_DEVIATION 5256 | 3217 pg/ml STANDARD_DEVIATION 4697 |
| Number of participants with New York Heart Association (NYHA) I,II,III,IV NYHA I | 0 Participants | 0 Participants | 0 Participants |
| Number of participants with New York Heart Association (NYHA) I,II,III,IV NYHA II | 128 Participants | 139 Participants | 267 Participants |
| Number of participants with New York Heart Association (NYHA) I,II,III,IV NYHA III | 28 Participants | 25 Participants | 53 Participants |
| Number of participants with New York Heart Association (NYHA) I,II,III,IV NYHA IV | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 156 Participants | 164 Participants | 320 Participants |
| Region of Enrollment Spain | 156 participants | 164 participants | 320 participants |
| Sex: Female, Male Female | 38 Participants | 45 Participants | 83 Participants |
| Sex: Female, Male Male | 118 Participants | 119 Participants | 237 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 145 | 3 / 144 |
| other Total, other adverse events | 20 / 145 | 22 / 144 |
| serious Total, serious adverse events | 11 / 145 | 2 / 144 |
Outcome results
Primary
BB % Relative Dose (Mean) With Regard to Target Dose
BB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | BB % Relative Dose (Mean) With Regard to Target Dose | 56.29 percentage of target dose | Standard Deviation 31.3 |
| HF Nurse Up-titration | BB % Relative Dose (Mean) With Regard to Target Dose | 71.09 percentage of target dose | Standard Deviation 31.05 |
p-value: <0.00195% CI: [7.5, 22.1]t-test, 2 sided
Secondary
6 Minute Walking Test
6 minute walking test improvement ( change) meters.Improvement (difference of change from baseline to 6 months between groups Six minute walking test. Measurement of exercise capacity is an integral element in assessment of patients with cardiopulmonary disease. It provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions. The six-minute walk test (6MWT) measures the distance (meters) an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | 6 Minute Walking Test | 50.49 meters | Standard Deviation 74.2 |
| HF Nurse Up-titration | 6 Minute Walking Test | 57.76 meters | Standard Deviation 79.97 |
p-value: 0.4495% CI: [-11.27, 25.83]t-test, 2 sided
Secondary
ACEI % Relative Dose (Mean) With Regard to Target Dose
ACEI mean Relative dose is the mean dose of ACEI achieved 4 months after starting titration, relative to target dose (%) described in European guidelines
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | ACEI % Relative Dose (Mean) With Regard to Target Dose | 56.13 percentage of target dose | Standard Deviation 30.4 |
| HF Nurse Up-titration | ACEI % Relative Dose (Mean) With Regard to Target Dose | 72.61 percentage of target dose | Standard Deviation 29.8 |
p-value: <0.00195% CI: [8.7, 24.3]t-test, 2 sided
Secondary
ARB % Relative Dose (Mean) With Regard to Target Dose
ARB, angiotensin II receptor blockers, mean relative dose ( % to target dose). Target dose is described in European guidelines. Measured at 4 months after starting titration.
Time frame: 4 months
Population: During the titration process several patients that at baseline did not have ARB prescription were prescribed this drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | ARB % Relative Dose (Mean) With Regard to Target Dose | 43.51 percentage of target dose | Standard Deviation 33.7 |
| HF Nurse Up-titration | ARB % Relative Dose (Mean) With Regard to Target Dose | 44.48 percentage of target dose | Standard Deviation 33.5 |
p-value: 0.9395% CI: [-15.1, 17.1]t-test, 2 sided
Secondary
Change in % Left Ventricular Ejection Fraction
Change in % Left Ventricular Ejection Fraction (difference of change from baseline to 6 months between groups) Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts.
Time frame: 6 months
Population: It has to be taken into account that in outcome mesasures the order of groups and their number of participants is reversed ( first HF cardiologist, second HF nurse) in regard to those in the participant flow. ( first HF nurse, second HF cardiologist)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Change in % Left Ventricular Ejection Fraction | 15.46 percentage of blood expelled/each beat | Standard Deviation 11.46 |
| HF Nurse Up-titration | Change in % Left Ventricular Ejection Fraction | 15.63 percentage of blood expelled/each beat | Standard Deviation 13.29 |
p-value: 0.9695% CI: [-2.69, 2.83]t-test, 2 sided
Secondary
European Quality of Life Scale: EuroQol- 5 Dimension Index
European Quality of Life Scale: EuroQol- 5 Dimension index (Range: 1 full health-0 death). It measures health status self-reported by the patient. It has 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels: 1 no problem; 2 some or moderate problems; 3 extreme problems. The EuroQol Research Foundation converts this information into a single summary index, by applying a formula that attaches specific country values (called weights) to each of the levels in each dimension. The index is calculated by subtracting the mentioned weights from 1, the value for full health. We measured the EuroQol-5D index improvement (change) from baseline to 6 months. More information in: EQ-5D-3L-User-Guide\_version-6.0 (1).pdf
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | European Quality of Life Scale: EuroQol- 5 Dimension Index | 0.04 score on a scale | Standard Deviation 0.28 |
| HF Nurse Up-titration | European Quality of Life Scale: EuroQol- 5 Dimension Index | 0.08 score on a scale | Standard Deviation 0.23 |
p-value: 0.295% CI: [-0.2, 0.28]t-test, 2 sided
Secondary
MRA % Relative Dose (Mean) With Regard to Target Dose
MRA % relative dose (mean) is the mean dose achieved 4 months after starting titration with regard to target dose (%) described in european guidelines
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | MRA % Relative Dose (Mean) With Regard to Target Dose | 70.47 percentage of target dose | Standard Deviation 29.8 |
| HF Nurse Up-titration | MRA % Relative Dose (Mean) With Regard to Target Dose | 71.00 percentage of target dose | Standard Deviation 32.1 |
p-value: 0.8695% CI: [-7.1, 8.2]t-test, 2 sided
Secondary
N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP)
Nt-proBNP (N-terminal pro-B type natriuretic peptide) Improvement (Decrease) difference of change from baseline to 6 months between groups, mean (SD)
Time frame: 6 months
Population: BNP was analysed in 11 patients of both groups, instead of Nt proBNP ( 121/117).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP) | -1577 pg/ml | Standard Deviation 3225 |
| HF Nurse Up-titration | N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP) | -1593 pg/ml | Standard Deviation 2733 |
p-value: 0.9795% CI: [-781, 748]t-test, 2 sided
Secondary
Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV
Number of participants class I-IV New York Heart Association (NYHA) functional classification, based on severity of symptoms and physical activity: NYHA I (better): No limitation of physical activity; NYHA II: Slight limitation of ordinary physical activity, breathlessness; NYHA III: marked limitation of physical activity. Comfortable at rest, but less than ordinary activity results in undue breathlessness, fatigue or palpitations; NYHA IV ( worse): unable to carry on any physical activity without discomfort.Symptoms at rest can be present. If any physical activity is undertaken discomfort is increased.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA I | 47 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA II | 86 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA III | 4 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA IV | 0 Participants |
| HF Nurse Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA IV | 0 Participants |
| HF Nurse Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA I | 59 Participants |
| HF Nurse Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA III | 4 Participants |
| HF Nurse Up-titration | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | NYHA II | 72 Participants |
Secondary
Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month)
Number of participants with Heart Rate (HR) \< 50 beats per minute during the titration process (from baseline to 4 month) , which could be associated to the titration process. (with or without symptoms)
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month) | 7 Participants |
| HF Nurse Up-titration | Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month) | 10 Participants |
p-value: 0.4495% CI: [-3.3, 7.54]Chi-squared
Secondary
Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month)
Number of participants with Potassium≥ 5.5 meq/l during the titration process (from baseline to 4 month) that could be associated to this titration process
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month) | 3 Participants |
| HF Nurse Up-titration | Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month) | 6 Participants |
p-value: 0.3195% CI: [-1.9, 6.1]Chi-squared
Secondary
Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month)
Description: Number of participants with symptomatic hypotension during the titration process (from baseline to 4 month) that could be associated to this titration process. Symptomatic hypotension defined as symptoms such as dizziness or light headedness, associated to hypotension
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month) | 13 Participants |
| HF Nurse Up-titration | Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month) | 12 Participants |
p-value: 0.8595% CI: [-7.1, 5.85]Chi-squared
Secondary
Number of Participants With Worsening Renal Function (From Baseline to 4th Month)
Number of participants with worsening renal function during the titration process (from baseline to 4 month) that could be associated to the titration process (Creatinine increase \>50% baseline creatinine or creatinine\>3mg/dl, or Estimated Glomerular Filtration\<25 ml/min/1.73 m2)
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Participants With Worsening Renal Function (From Baseline to 4th Month) | 6 Participants |
| HF Nurse Up-titration | Number of Participants With Worsening Renal Function (From Baseline to 4th Month) | 4 Participants |
p-value: 0.5295% CI: [-3.33, 6.32]Chi-squared
Secondary
Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)
number of paticipants with drug Stop ( withdrawal) that occur during the titration process that could be due to an adverse event. ( it can be not only due to an adverse event but because there is no need of this drug or its substitution for another kind of drug)
Time frame: 4 months
Population: Participants analyzed are only participants with drug withdrawal
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | ARB stop | 0 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | betablocker stop | 3 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | MRA stop | 6 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | ACEI stop | 3 Participants |
| HF Nurse Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | MRA stop | 7 Participants |
| HF Nurse Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | betablocker stop | 1 Participants |
| HF Nurse Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | ARB stop | 1 Participants |
| HF Nurse Up-titration | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | ACEI stop | 0 Participants |
Secondary
Number of Patients: Mortality Due to Titration
Number of patients: Mortality due to titration ( not due to other causes)
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients: Mortality Due to Titration | 0 Participants |
| HF Nurse Up-titration | Number of Patients: Mortality Due to Titration | 0 Participants |
Secondary
Number of Patients With Admissions Due to Heart Failure (HF)
Number of patients with hospital admissions due to Heart Failure. From Baseline to 6 months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients With Admissions Due to Heart Failure (HF) | 9 Participants |
| HF Nurse Up-titration | Number of Patients With Admissions Due to Heart Failure (HF) | 1 Participants |
p-value: 0.0195% CI: [-9.7, -1.4]Chi-squared
Secondary
Number of Patients With Admissions Due to Titration
Number of patients with admissions due to titration ( not due to other causes)
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients With Admissions Due to Titration | 0 Participants |
| HF Nurse Up-titration | Number of Patients With Admissions Due to Titration | 0 Participants |
Secondary
Number of Patients With Atrio Ventricular (AV) Block Due to Titration
Number of patients with AV Block during the titration process, associated to the BB titration
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients With Atrio Ventricular (AV) Block Due to Titration | 0 Participants |
| HF Nurse Up-titration | Number of Patients With Atrio Ventricular (AV) Block Due to Titration | 0 Participants |
Secondary
Number of Patients With Deaths
Number of Patients with deaths due to Cardiovascular and non cardiovascular causes
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients With Deaths | mortality due to cardiovascular causes | 2 Participants |
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients With Deaths | mortality due to non cardiovascular causes | 2 Participants |
| HF Nurse Up-titration | Number of Patients With Deaths | mortality due to cardiovascular causes | 2 Participants |
| HF Nurse Up-titration | Number of Patients With Deaths | mortality due to non cardiovascular causes | 1 Participants |
p-value: 0.7195% CI: [-4.2, 2.87]Chi-squared
Secondary
Number of Patients With Worsening of Heart Failure Signs and Symptoms
Number of patients with worsening of heart failure signs and symptoms during the titration process ( from baseline to 4 month) which could be associated to the titration process.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Number of Patients With Worsening of Heart Failure Signs and Symptoms | 1 Participants |
| HF Nurse Up-titration | Number of Patients With Worsening of Heart Failure Signs and Symptoms | 2 Participants |
p-value: 0.5695% CI: [-1.6, 3.04]Chi-squared
Secondary
Quality of Life: MLWHFQ
Quality of Life, measured by Minnesota Living with Heart Failure Questionnaire. Improvement (change) from baseline to 6 months. Minnesota Living With Heart Failure Questionnaire (MLWHFQ). The content of this questionnaire was selected to be representative of the ways heart failure and treatments can affect the key physical, emotional, social and mental dimensions of quality of life of patients with heart failure. It consist of 21-items with score 0-5. Final evaluation moves from 0 (none) to 105 (very much); a lower score means better quality of life.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure (HF) Cardiologist Up-titration | Quality of Life: MLWHFQ | -25.01 score on a scale | Standard Deviation 23.22 |
| HF Nurse Up-titration | Quality of Life: MLWHFQ | -26.37 score on a scale | Standard Deviation 24.53 |
p-value: 0.7595% CI: [-6.63, 4.81]t-test, 2 sided