Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
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| First Received Date ICMJE | December 23, 2011 | ||||||||||||
| Last Updated Date | November 30, 2012 | ||||||||||||
| Start Date ICMJE | November 2007 | ||||||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT01500759 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry | ||||||||||||
| Official Title ICMJE | Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational [Patient Registry] | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 4 Weeks | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 12000 | ||||||||||||
| Estimated Completion Date | March 2015 | ||||||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia, Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01500759 | ||||||||||||
| Other Study ID Numbers ICMJE | 001 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | ResMed | ||||||||||||
| Study Sponsor ICMJE | ResMed | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | ResMed | ||||||||||||
| Verification Date | November 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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