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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT01538069
Eligibility Criteria:
Inclusion Criteria:
* Age range 20-70 years
* New York Heart Association Class II-III
* Clinically stable for one month
* Ejection fraction \<40%
* Peak VO2 \<20 ml/kg/min
* Stable and optimized medical therapy at least one month before the study
* B-blocker therapy
* Clinical and polysomnographic diagnosis of sleep apnea (IAH\>10)
Exclusion Criteria:
* Patients with previous treatment of sleep apnea
* New York Heart Association Class IV
* Clinical instability
* Poor adherence to drug treatment
* Myocardial infarction or revascularization within the past two months
* Unstable angina
* Symptomatic arrhythmias (pacemaker and defibrillator)
* Obstructive aortic or mitral valvular disease
* Hypertrophic cardiomyopathy
* Abnormal exercise testing
* Pulmonary arterial pressure \>50mmHg
* Chronic obstructive pulmonary disease
* Intermittent leg claudication
* Musculoskeletal disorders or psychiatric disease that prevents the patient from understanding and following the exercise prescription safely
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01538069
Study Brief:
Protocol Section:
NCT01538069