Genomic Response Analysis of Heart Failure Therapy in African Americans
Status:
Active, not recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
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 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.