Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry (SchlaHF)
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|ClinicalTrials.gov Identifier: NCT01500759|
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : August 5, 2015
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|
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 [Patient Registry]|
|Actual Enrollment :||10775 participants|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT01500759
|Principal Investigator:||Erland Erdmann, Prof||Klinikum der Universität zu Köln|
|Principal Investigator:||Helmut Teschler, Prof||Ruhrlandklinik Essen|
|Study Director:||Holger Woehrle, MD||ResMed|