Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure

Conditions
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Congestive Heart Failure, Left Ventricular Systolic Dysfunction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of SDB in Chronic HF Patients | SDB= Sleep disordered breathing; HF= Heart failure | 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution | 
| Age | Age years | 1-time single assessment at baseline | 
| Body Mass Index |  | 1-time single assessment at baseline | 
| Male Gender |  | 1-time single assessment at baseline | 
| 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. | At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records | 
| 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. | 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records. | 
| 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 | Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep | 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility | 
| Oxygen Desaturation Index | Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value. | 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility | 
| Mean SpO2 | Saturation of oxygen | 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility | 
| Min SpO2 | Lowest Saturation with oxygen | 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility | 
| Medication ACE Inhibitors and/ARBs | ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker | 1-time: At baseline medication was assessed 1 time (anamnesis) | 
| 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 | 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | 
| 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | 
| 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | 
| 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, heart failure, hf, sleep-disordered breathing, sdb, nyha, lvef, cheyne stokes, central sleep apnoea, sleep apnoea