Status:
COMPLETED
Genomic Response Analysis of Heart Failure Therapy in African Americans
Lead Sponsor:
University of Pittsburgh
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when c...
Detailed Description
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when c...
Eligibility Criteria
Inclusion
- 18 years and older
- 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\*\*
- New York Heart Association (NYHA) Class II-IV
- 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)
- 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
- History of intolerance to either nitrates or hydralazine
- Treatment with the combination of hydralazine and nitrates for the previous 3 months
- Revascularization or myocardial infarction within last 90 days
- 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
- 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)
- Women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy.
- Subjects who are on continuous home inotropes, a left ventricular assist device, or who are post cardiac transplant.
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT02305095
Start Date
May 1 2015
End Date
September 30 2022
Last Update
April 20 2023
Active Locations (19)
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1
University of Alabama Medical Center
Tuscaloosa, Alabama, United States, 35401
2
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
3
Emory University
Atlanta, Georgia, United States, 30322
4
Northwestern University
Chicago, Illinois, United States, 60611