Genomic Response Analysis of Heart Failure Therapy in African Americans

Completed

Conditions studied: Heart Failure

In brief

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 compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.

Key facts

Study ID

NCT02305095

Run by

University of Pittsburgh

People needed

225

Starts

2015-05-01

Expected to finish

2022-09-30

Last updated by the study team

2023-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Alabama Medical Center — Tuscaloosa, Alabama, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Illinois of Chicago — Chicago, Illinois, United States
• Tulane University Heart and Vascular Institute — New Orleans, Louisiana, United States
• Ochsner — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachsetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Rutgers University Health Center — Newark, New Jersey, United States
• Montefiore Medical Center Bronx New York — The Bronx, New York, United States
• MetroHealth System — Cleveland, Ohio, United States
• Temple University Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of South Carolina — Charleston, South Carolina, United States
• Stern Cardiovascular Foundation — Germantown, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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