Contact Information

Department Information

Cardiology

Principal Investigator

Adefisayo Oduwole, MD

Coordinator

JoAnn Cross, RN

Clinicaltrials.gov Details

Identifier

NCT02305095/Heart Failure

First Received Date

September 25, 2014

View on Clinicaltrials.gov

Genomic Response Analysis of Heart Failure Therapy in African Americans (GRAHF-2)

Active

Purpose

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.

Start Date

May 2015

End Date

April 2019

Investigator(s)

Adefisayo Oduwole, MD

Interventions

Drug: FDC I/H

Eligibility

Ages Eligible for Study: 18 years and older (Adult, Senior)

Sexes Eligible for Study: All

Accepts Healthy Volunteer: No