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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 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.

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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.

Conditions Studied

Heart Failure

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

FieldValue
Enrollment Target 225 participants
Start Date 2015-05-01
Est. Completion 2022-09-30

Sponsor

University of Pittsburgh

1,238 total trials

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What the Registry Record Tells You About NCT02305095

The ClinicalTrials.gov registry entry for NCT02305095 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (89% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

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 reports 19 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.