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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT01500759
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01500759
Study Brief:
Protocol Section:
NCT01500759