Genomic Response Analysis of Heart Failure Therapy in African Americans
Public ClinicalTrials.gov record NCT02305095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Genomic Analysis of the Enhanced Response to Heart Failure Therapy in African Americans
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02305095
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2015 (Actual)
- Primary completion
- Dec 31, 2020 (Actual)
- Completion
- Sep 30, 2022 (Actual)
- Last update posted
- Apr 20, 2023
2015 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Medical Center | Tuscaloosa | Alabama | 35401 | — |
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Illinois of Chicago | Chicago | Illinois | 60612 | — |
| Tulane University Heart and Vascular Institute | New Orleans | Louisiana | 70112 | — |
| Ochsner | New Orleans | Louisiana | 70121 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Massachsetts General Hospital | Boston | Massachusetts | 02113 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Rutgers University Health Center | Newark | New Jersey | 07102 | — |
| Montefiore Medical Center Bronx New York | The Bronx | New York | 10461 | — |
| MetroHealth System | Cleveland | Ohio | 44109 | — |
| Temple University Medical Center | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| University of South Carolina | Charleston | South Carolina | 29425 | — |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02305095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 20, 2023 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02305095 live on ClinicalTrials.gov.