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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01919918
Eligibility Criteria:
Heart Failure Inclusion Criteria:
* Subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, greater than 1 year duration, ages 20-79 years)
* New York Heart Association class I through IV symptoms
* Left ventricular ejection fraction less than 35 percent (heart failure patients with reduced left ventricular ejection fraction) or greater than 50 percent (heart failure patients with preserved left ventricular ejection fraction)
* Sedentary, no regular physical activity for at least 6 months prior
* Post-menopausal for at least 2 years and follicle stimulating hormone greater than 40
Heart Failure Exclusion Criteria:
* Patients with atrial fibrillation or heart failure believed to be secondary to atrial fibrillation
* Morbidly obese patients with a body mass index greater than 35
* Patients with uncontrolled hypertension, greater than 160/100
* Anemia with a hemoglobin less than 9
* Severe renal insufficiency (creatinine clearance less than 30 by the Cockcroft-Gault formula)
* Patients with significant non-cardiac comorbidities
* Orthopedic limitations that would prohibit them from performing the elbow-flexor exercise
* Current smoker or smoking history of 15 packs or more per year
* Women currently taking hormone replacement therapy
Healthy Control Inclusion Criteria:
* Ages 20-75 years
* Sedentary, no regular physical activity for at least 6 months prior
* Post-menopausal for at least 2 years and follicle stimulating hormone greater than 40
Healthy Control Exclusion Criteria:
* History of cardiovascular related abnormalities or pulmonary abnormalities
* Morbidly obese patients with a body mass index greater than 35
* Patients with uncontrolled hypertension, greater than 160/100
* Anemia with a hemoglobin less than 9
* Orthopedic limitations that would prohibit them from performing the elbow-flexor exercise
* Current smoker or smoking history of 15 packs or more per year
* Women currently taking hormone replacement therapy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT01919918
Study Brief:
Protocol Section:
NCT01919918