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

Completed

Conditions: Left Ventricular Systolic Dysfunction
Congestive Heart Failure

Registration Number: NCT01500759

Lead Sponsor: ResMed

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6876

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Male Gender	1-time single assessment at baseline
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
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.
Mean SpO2	1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility	Saturation of oxygen
Min SpO2	1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility	Lowest Saturation with oxygen
Diuretics	1-time: At baseline medication was assessed 1 time (anamnesis)
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
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.
Nocturnal Dyspnea	1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records
Medication ACE Inhibitors and/ARBs	1-time: At baseline medication was assessed 1 time (anamnesis)	ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker
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
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.
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
Beta-blocker	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)
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
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
Body Mass Index	1-time single assessment at baseline
Age	1-time single assessment at baseline	Age years

Trial Locations

Locations (199): Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
Rivercity Private Hospital
🇦🇺
Auchenflower, Queensland, Australia
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Melbourne Sleep Disorders Centre
🇦🇺
East Melbourne, Victoria, Australia
Baker IDI Heart and Diabetes Institute
🇦🇺
Melbourne, Victoria, Australia
St Vincents and Mercy Private Hospital
🇦🇺
Melbourne, Victoria, Australia
Hollywood Private Hospital (CVS)
🇦🇺
Nedlands, Western Australia, Australia
Cardiopraxis Ingelheim
🇩🇪
Ingelheim am Rhein, Rheinland-Pfalz, Germany
Praxis Dr. Frieske
🇩🇪
Aachen, Germany
Universitätsklinikum Aachen
🇩🇪
Aachen, Germany
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Westmead Hospital
🇦🇺Westmead, New South Wales, Australia