Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01164592
Eligibility Criteria:
The inclusion and exclusion criteria are mainly those applicable for the parent study; SERVE-HF. The inclusion and exclusion criteria are listed here.
INCLUSION CRITERIA FOR SERVE-HF STUDY:
* Over 22 years of age
* Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
* Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
* Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of \>15/hr with at least 50% central events and a central AHI of at least 10/hr
* Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
* Optimised medical treatment according to the applicable guidelines
* Able to provide informed consent
ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY
• Predominant central sleep apnoea (apnoea hypopnoea index \> 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula
EXCLUSION CRITERIA FOR THE SERVE-HF STUDY:
* Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)\<50% predicted
* Oxygen saturation at rest during the day 90% at the time of inclusion
* Current use of Positive Airway Pressure (PAP) therapy
* Life expectancy \< 1 year for diseases unrelated to chronic heart failure
* Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
* Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) 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)
* Pregnancy
ADDITIONAL EXCLUSION CRITERIA FOR THE SUBSTUDY
* Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
* Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT01164592
Study Brief:
Protocol Section:
NCT01164592