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Genomic Response Analysis of Heart Failure Therapy in African Americans

NCT02305095 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2023-04-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

FDC I/H

All subjects in both groups will be initiated on drug, FDC I/H with dose titrated up to target doses based on clinical guidelines

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Dennis McNamara, MD · University of Pittsburgh Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2020-12-31
Completion
2022-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305095 on ClinicalTrials.gov