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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01615094
Eligibility Criteria:
Inclusion Criteria:
1. Age range 18 years or older
2. ACC/AHA classification Stage B HF patients
3. Receiving optimal treatment according to their cardiologist and/or internists
4. An echocardiogram within the past 12 months
5. Ejection fraction: as described below in Initial Screening and Identification of Stage B Patients
6. Men and women of all ethnicities and races
7. Ability and physician clearance to perform mild exercise
8. With and without depressive symptoms and DSM-IV MDD
9. Ability to fully understand all elements of and sign the written informed consent before initiation of the study
Exclusion Criteria:
1. History of recent myocardial infarction (3 months)
2. Significant aortic or mitral stenosis, angina not adequately managed with nitrates
3. Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 2 months
4. Hypertension \>180/110 mm Hg
5. Recent stroke or significant cerebral neurological impairment
6. Severe COPD, patients who require mechanical ventilation, with cardiogenic shock, volume depletion
7. Subjects with high suicide risk
8. Immune-related disorders including infectious diseases and autoimmune and inflammatory disorders
9. Morbid Obesity: BMI \> 40 due to likelihood of inability to perform exercise
10. Women who are pregnant or nursing
11. Major mental illness as determined by referring provider
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01615094
Study Brief:
Protocol Section:
NCT01615094