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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT02305095
Eligibility Criteria:
Inclusion Criteria:
1. 18 years and older
2. History of heart failure with an LVEF (less than OR equal to) \< 0.35 for at least 6 months OR an LVEF \< 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area OR more than 6.5 cm on the basis of echocardiography). \*\* Echo must be done within 6 months of enrollment\*\*
3. New York Heart Association (NYHA) Class II-IV
4. Background heart failure therapy that includes angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), and beta blockers (BBs) for at least 3 months (or documentation of intolerance to ACEi/ARBs and BBs)
5. Self-designated race as African American or black (would include subjects whose country of origin was outside the USA such as Africa, the Caribbean, or Central America).
Exclusion Criteria:
1. History of intolerance to either nitrates or hydralazine
2. Treatment with the combination of hydralazine and nitrates for the previous 3 months
3. Revascularization or myocardial infarction within last 90 days
4. Received cardiac resynchronization therapy (CRT) AND did not have an assessment of cardiac function documenting an LVEF \< 35% (less than OR equal to 35%) at least 90 days post CRT
5. Presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension. (Note that uncontrolled hypertension is defined as blood pressure consistently greater than 160 mmHg systolic and 95 mmHg diastolic)
6. Women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy.
7. Subjects who are on continuous home inotropes, a left ventricular assist device, or who are post cardiac transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02305095
Study Brief:
Protocol Section:
NCT02305095