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Completed

NCT Number: NCT01500759

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

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.

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Key information

Conditions

Congestive Heart Failure Apnea Cardiovascular Diseases Cheyne-Stokes Respiration Dyssomnias Heart Diseases Heart Failure Left Ventricular Systolic Dysfunction Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of SDB in Chronic HF Patients

    Time frame: 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 outcomes

  1. Left Ventricular Ejection Fraction

    Time frame: 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

  2. Age

    Time frame: 1-time single assessment at baseline

    Age years

  3. Body Mass Index

    Time frame: 1-time single assessment at baseline

  4. Male Gender

    Time frame: 1-time single assessment at baseline

  5. NYHA Class ≥III

    Time frame: 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.

  6. Ischemic Etiology

    Time frame: 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.

  7. 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

  8. Nocturnal Dyspnea

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

  9. Nocturia ≥3 Times/Night

    Time frame: 1-time: At baseline nocturia was assessed 1 time (anamnesis)

  10. Apnoea-Hypopnea-Index

    Time frame: 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

  11. Oxygen Desaturation Index

    Time frame: 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.

  12. Mean SpO2

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

    Saturation of oxygen

  13. Min SpO2

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

    Lowest Saturation with oxygen

  14. Medication ACE Inhibitors and/ARBs

    Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)

    ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker

  15. Beta-blocker

    Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)

  16. Diuretics

    Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)

  17. Digitalis

    Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)

  18. Aldosterone Antagonists

    Time frame: 1-time: At baseline medication was assessed 1 time (anamnesis)

  19. Male Gender as Predictor for SDB in Chronic HF

    Time frame: 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

  20. Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF

    Time frame: 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

  21. Ischemic Etiology as Predictor for SDB in Chronic HF

    Time frame: 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

  22. NYHA Class >= III as Predictor for SDB in Chronic HF

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Acronym: SchlaHF

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2011
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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