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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02322034
Eligibility Criteria:
Inclusion Criteria:
* Stable New York Heart Association (NYHA) class II or III
* Resting left ventricular ejection fraction below 40%
* Measured peak VO2 below 14 ml/kg/min \[Patients must be stable on prescribed cardiac medication for 1 month prior to entering the study\]
Exclusion Criteria:
* myocardial infarction within 12 months prior to study entry;
* unstable angina; resting systolic blood pressure above 200 mmHg, or diastolic blood pressure above 110 mmHg;
* fever of unknown significance;
* critical aortic stenosis (peak systolic pressure gradient \> 50 mm Hg with an aortic valve orifice area \< 0.75 cm2 in average size adult);
* uncontrolled atrial or ventricular arrhythmias such as uncontrolled sinus tachycardia (\> 120 beats.min-1);
* II or greater atrio-ventricular block;
* active pericarditis or myocarditis;
* recent embolism and thrombophlebitis;
* uncontrolled diabetes HbA1C%\>9.5%;
* severe orthopedic or other medical conditions that would prohibit exercise;
* metabolic conditions such as acute thyroiditis, hypokalemia or hyperkalemia and hypovolemia;
* severe renal dysfunction (i.e. creatinine plasma levels \>2.5 mg/dl);
* severe concomitant non-cardiac diseases such as cancer, dementia or any systemic disease limiting exercise;
* inability to participate in a prospective study for any logistic reason
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02322034
Study Brief:
Protocol Section:
NCT02322034