Congestive Heart Failure, Left Ventricular Systolic Dysfunction
Conditions
Keywords
chronic heart failure, heart failure, hf, sleep-disordered breathing, sdb, nyha, lvef, cheyne stokes, central sleep apnoea, sleep apnoea
Brief summary
Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb. For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.
Detailed description
Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure. Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure. Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF. For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate. Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.
Interventions
None listed
Sponsors
ResMed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be over 18 * Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines * Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks * NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months * Patient is able to fully understand study information and signed informed consent
Exclusion criteria
* Life expectancy \< 1 year for diseases unrelated to chronic HF * Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months * CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months * Transient ischemic attack (TIA) or Stroke within 3 months * Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery * Acute myocarditis/pericarditis within 6 months * Current CPAP or bilevel therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of SDB in Chronic HF Patients | 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility | SDB= Sleep disordered breathing; HF= Heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age | 1-time single assessment at baseline | Age years |
| Body Mass Index | 1-time single assessment at baseline | — |
| Male Gender | 1-time single assessment at baseline | — |
| NYHA Class ≥III | At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records | New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations. |
| Ischemic Etiology | 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records. | Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) ischemic in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology. |
| Atrial Fibrillation | 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records | — |
| Nocturnal Dyspnea | 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records | — |
| Nocturia ≥3 Times/Night | 1-time: At baseline nocturia was assessed 1 time (anamnesis) | — |
| Apnoea-Hypopnea-Index | 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility | Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep |
| Oxygen Desaturation Index | 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility | Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value. |
| Left Ventricular Ejection Fraction | 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution | Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole |
| Min SpO2 | 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility | Lowest Saturation with oxygen |
| Medication ACE Inhibitors and/ARBs | 1-time: At baseline medication was assessed 1 time (anamnesis) | ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker |
| Beta-blocker | 1-time: At baseline medication was assessed 1 time (anamnesis) | — |
| Diuretics | 1-time: At baseline medication was assessed 1 time (anamnesis) | — |
| Digitalis | 1-time: At baseline medication was assessed 1 time (anamnesis) | — |
| Aldosterone Antagonists | 1-time: At baseline medication was assessed 1 time (anamnesis) | — |
| Male Gender as Predictor for SDB in Chronic HF | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure |
| Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure |
| Ischemic Etiology as Predictor for SDB in Chronic HF | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure |
| NYHA Class >= III as Predictor for SDB in Chronic HF | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure |
| Mean SpO2 | 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility | Saturation of oxygen |
Countries
Australia, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic HF Without SDB Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) | 3,686 |
| Chronic HF With SDB Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) | 3,190 |
| Total | 6,876 |
Baseline characteristics
| Characteristic | Chronic HF Without SDB | Chronic HF With SDB | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12 | 69 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 932 Participants | 516 Participants | 1448 Participants |
| Sex: Female, Male Male | 2754 Participants | 2674 Participants | 5428 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3,686 | 0 / 3,190 |
Outcome results
Primary
Prevalence of SDB in Chronic HF Patients
SDB= Sleep disordered breathing; HF= Heart failure
Time frame: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Prevalence of SDB in Chronic HF Patients | 3190 Participants |
Secondary
Age
Age years
Time frame: 1-time single assessment at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Age | 65 years | Standard Deviation 12 |
| Chronic HF With SDB | Age | 69 years | Standard Deviation 11 |
Secondary
Aldosterone Antagonists
Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Aldosterone Antagonists | 1808 Participants |
| Chronic HF With SDB | Aldosterone Antagonists | 1454 Participants |
Secondary
Apnoea-Hypopnea-Index
Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep
Time frame: 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Apnoea-Hypopnea-Index | 6 events/hour | Standard Deviation 4 |
| Chronic HF With SDB | Apnoea-Hypopnea-Index | 31 events/hour | Standard Deviation 14 |
Secondary
Atrial Fibrillation
Time frame: 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Atrial Fibrillation | 863 Participants |
| Chronic HF With SDB | Atrial Fibrillation | 1001 Participants |
Secondary
Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF
From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure
Time frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF | 863 Participants |
| Chronic HF With SDB | Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF | 1001 Participants |
Secondary
Beta-blocker
Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Beta-blocker | 3284 Participants |
| Chronic HF With SDB | Beta-blocker | 2824 Participants |
Secondary
Body Mass Index
Time frame: 1-time single assessment at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Body Mass Index | 28.1 kg/m˄2 | Standard Deviation 5 |
| Chronic HF With SDB | Body Mass Index | 28.9 kg/m˄2 | Standard Deviation 5.2 |
Secondary
Digitalis
Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Digitalis | 717 Participants |
| Chronic HF With SDB | Digitalis | 599 Participants |
Secondary
Diuretics
Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Diuretics | 2805 Participants |
| Chronic HF With SDB | Diuretics | 2617 Participants |
Secondary
Ischemic Etiology
Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) ischemic in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.
Time frame: 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Ischemic Etiology | 1961 Participants |
| Chronic HF With SDB | Ischemic Etiology | 1742 Participants |
Secondary
Ischemic Etiology as Predictor for SDB in Chronic HF
From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure
Time frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Ischemic Etiology as Predictor for SDB in Chronic HF | 1961 Participants |
| Chronic HF With SDB | Ischemic Etiology as Predictor for SDB in Chronic HF | 1742 Participants |
Secondary
Left Ventricular Ejection Fraction
Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole
Time frame: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Left Ventricular Ejection Fraction | 33.6 % ejection fraction | Standard Deviation 8 |
| Chronic HF With SDB | Left Ventricular Ejection Fraction | 32.8 % ejection fraction | Standard Deviation 8.3 |
Secondary
Male Gender
Time frame: 1-time single assessment at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Male Gender | 2754 Participants |
| Chronic HF With SDB | Male Gender | 2674 Participants |
Secondary
Male Gender as Predictor for SDB in Chronic HF
From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure
Time frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Male Gender as Predictor for SDB in Chronic HF | 2754 Participants |
| Chronic HF With SDB | Male Gender as Predictor for SDB in Chronic HF | 2674 Participants |
Secondary
Mean SpO2
Saturation of oxygen
Time frame: 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Mean SpO2 | 93 %oxygen saturation | Standard Deviation 2 |
| Chronic HF With SDB | Mean SpO2 | 92 %oxygen saturation | Standard Deviation 3 |
Secondary
Medication ACE Inhibitors and/ARBs
ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker
Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Medication ACE Inhibitors and/ARBs | 3269 Participants |
| Chronic HF With SDB | Medication ACE Inhibitors and/ARBs | 2812 Participants |
Secondary
Min SpO2
Lowest Saturation with oxygen
Time frame: 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Min SpO2 | 83 % oxygen saturation | Standard Deviation 6 |
| Chronic HF With SDB | Min SpO2 | 80 % oxygen saturation | Standard Deviation 6 |
Secondary
Nocturia ≥3 Times/Night
Time frame: 1-time: At baseline nocturia was assessed 1 time (anamnesis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Nocturia ≥3 Times/Night | 580 Participants |
| Chronic HF With SDB | Nocturia ≥3 Times/Night | 660 Participants |
Secondary
Nocturnal Dyspnea
Time frame: 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | Nocturnal Dyspnea | 672 Participants |
| Chronic HF With SDB | Nocturnal Dyspnea | 800 Participants |
Secondary
NYHA Class ≥III
New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.
Time frame: At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | NYHA Class ≥III | 2566 Participants |
| Chronic HF With SDB | NYHA Class ≥III | 2341 Participants |
Secondary
NYHA Class >= III as Predictor for SDB in Chronic HF
From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure
Time frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic HF With SDB | NYHA Class >= III as Predictor for SDB in Chronic HF | 2566 Participants |
| Chronic HF With SDB | NYHA Class >= III as Predictor for SDB in Chronic HF | 2341 Participants |
Secondary
Oxygen Desaturation Index
Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.
Time frame: 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic HF With SDB | Oxygen Desaturation Index | 8 events/hour | Standard Deviation 10 |
| Chronic HF With SDB | Oxygen Desaturation Index | 24 events/hour | Standard Deviation 15 |