Status:
COMPLETED
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Lead Sponsor:
ResMed
Conditions:
Congestive Heart Failure
Left Ventricular Systolic Dysfunction
Eligibility:
All Genders
18+ years
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 purp...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
6876 Patients enrolled
Trial Details
Trial ID
NCT01500759
Start Date
November 1 2007
End Date
May 1 2013
Last Update
July 9 2020
Active Locations (199)
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1
Westmead Hospital
Westmead, New South Wales, Australia, 2145
2
Rivercity Private Hospital
Auchenflower, Queensland, Australia, 4066
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004