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NCT02305095 · ClinicalTrials.gov registry record
Genomic Response Analysis of Heart Failure Therapy in African Americans
A clinical trial of Heart Failure, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 225
- Enrollment target
- 19
- Study locations
NCT02305095: Completed study of Heart Failure, sponsored by University of Pittsburgh.
NCT02305095 is a study of Heart Failure that has completed, run by University of Pittsburgh. The registered enrollment target is 225 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (89% lower). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02305095, a study of Heart Failure, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 225 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
The CS combines three outcome variables into a single "score". Composite score adds points for survival over 2 years of follow up (death at any time yields -3 points, survival to end of study results in 0), heart failure hospitalization over 2 years of follow up (yes at any time results in -1 point, no results in 0), and the change in the raw quality of life score on the Minnesota Living with Heart Failure Questionnaire from entry to 6 months (change of ten units or greater=increase +2, decrease
Conditions Studied
Interventions
- DRUG FDC I/H
Study Locations (19)
Georgia
- Morehouse School of Medicine - Atlanta
- Emory University - Atlanta
Illinois
- Northwestern University - Chicago
- University of Illinois of Chicago - Chicago
Louisiana
- Tulane University Heart and Vascular Institute - New Orleans
- Ochsner - New Orleans
Pennsylvania
- Temple University Medical Center - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Alabama
- University of Alabama Medical Center - Tuscaloosa
Maryland
- University of Maryland Medical Center - Baltimore
Massachusetts
- Massachsetts General Hospital - Boston
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2015-05-01 |
| Est. Completion | 2022-09-30 |
What the finished NCT02305095 record still lists
NCT02305095 is an observational study that tracks outcomes without assigning an intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which FDC I/H is the first listed.
NCT02305095 lists 19 locations in 15 states (Georgia, Illinois, Louisiana).
Frequently Asked Questions
What is clinical trial NCT02305095 about?
NCT02305095 is a clinical study titled "Genomic Response Analysis of Heart Failure Therapy in African Americans". 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 fro...
What is the current status of trial NCT02305095?
This trial is currently completed. The enrollment target is 225 participants. The study started on 2015-05-01. Estimated completion is 2022-09-30.
What conditions does trial NCT02305095 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT02305095?
The interventions under investigation include: FDC I/H (DRUG).
Who is sponsoring clinical trial NCT02305095?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02305095 being conducted?
This trial has 19 study locations across Alabama, Georgia, Illinois, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02305095's enrollment target sits among peer trials
225 155th of 397 higher than 242 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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