Description:

ODM derived from http://clinicaltrials.gov/show/NCT00733343

Link:

http://clinicaltrials.gov/show/NCT00733343

Keywords:
Versions (2) ▾
  1. 12/6/13
  2. 4/16/14
Uploaded on:

April 16, 2014

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License:
Creative Commons BY 4.0
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Eligibility NCT00733343 Heart Failure

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 22 Years
Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
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 before randomisation
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
No hospitalisation for heart failure for at least 4 weeks prior to inclusion
Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
SDB (AHI > 15/h with >= 50% central events and a central AHI >= 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
Patients for whom the use of AutoSet CS2/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
Patient is able to fully understand study information and signed informed consent
Exclusion Criteria
Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
Oxygen saturation at rest during the day <= 90% at inclusion
Current use of Positive Airway Pressure (PAP) - therapy
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 prior to randomisation
CRT-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
Acute myocarditis/pericarditis within 6 months prior to randomisation
Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
Pregnancy, Gestation