Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01500759
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : August 5, 2015
Information provided by (Responsible Party):

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.

Condition or disease
Congestive Heart Failure Left Ventricular Systolic Dysfunction

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 10775 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
Study Start Date : November 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with Chronic Heart Failure with LVEF ≤ 45% and NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 24 months.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01500759

Show Show 199 study locations
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Erland Erdmann, Prof Klinikum der Universität zu Köln
Principal Investigator: Helmut Teschler, Prof Ruhrlandklinik Essen
Study Director: Holger Woehrle, MD ResMed

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ResMed Identifier: NCT01500759    
Other Study ID Numbers: 001
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by ResMed:
chronic heart failure
heart failure
sleep-disordered breathing
cheyne stokes
central sleep apnoea
sleep apnoea
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases