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

ResMed6,876 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

6,876

Conditions

Congestive Heart Failure Left Ventricular Systolic Dysfunction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (199)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Age

Age years

Time frame: 1-time single assessment at baseline

Body Mass Index

Time frame: 1-time single assessment at baseline

Male Gender

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Westmead Hospital

Westmead, New South Wales, Australia

Rivercity Private Hospital

Auchenflower, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, Australia

St Vincents and Mercy Private Hospital

Melbourne, Victoria, Australia

Melbourne Sleep Disorders Centre

East Melbourne, Victoria 3002, Australia

Hollywood Private Hospital (CVS)

Nedlands, Western Australia, Australia

Cardiopraxis Ingelheim

Ingelheim, Rhineland-Palatinate, Germany

Praxis Dr. Frieske

Aachen, Germany

Universitätsklinikum Aachen

Aachen, Germany

...and 189 more locations

Time frame: 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.

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

Nocturnal Dyspnea

Time frame: 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records

Nocturia ≥3 Times/Night

Time frame: 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

Time frame: 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.

Time frame: 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility

Mean SpO2

Saturation of oxygen

Time frame: 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility

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

Medication ACE Inhibitors and/ARBs

ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker