Evidence map›Paper›PMID 15533851›Full record

Trial reportThe New England journal of medicine2004

Combination of isosorbide dinitrate and hydralazine in blacks with heart failure.

Anne L Taylor, Susan Ziesche, Clyde Yancy, Peter Carson, Ralph D'Agostino, Keith Ferdinand, Malcolm Taylor, Kirkwood Adams, Michael Sabolinski, Manuel Worcel and 2 more

Erratum issued 2 registry-linked trialsAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 423 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
423citing papers in PubMed, 12 pooled it
73.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01772108 naterminatednot on this mapstarted 2013, after this paper: background citation

A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

TypeinterventionalSponsorAbbott Medical DevicesRan2013 to 2015Enrolled42ConditionsCardiovascular DiseasesArmsMitraClip
NCT03012022 active not recruitingnot on this mapstarted 2010, after this paper: background citation

Nitrative Stress in Heart Failure: The Cleveland Heart and Metabolic Prevention Study (CHAMPS)

TypeobservationalSponsorThe Cleveland ClinicRan2010 to 2027Enrolled1,208ConditionsHeart Failure Risk Factors in Healthy Individuals
3 · Its place in the literature

Who cites it

423 citing papers in PubMed, 12 syntheses or guidelines pooled it, 1,768 citations in OpenAlex.

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363 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Anne L TaylorDepartment of Medicine/Cardiology, University of Minnesota Medical School, Minneapolis 55455, USA. taylo135@umn.edu
Susan Ziesche
Clyde Yancy
Peter Carson
Ralph D'Agostino
Keith Ferdinand
Malcolm Taylor
Kirkwood Adams
Michael Sabolinski
Manuel Worcel
Jay N Cohn
African-American Heart Failure Trial Investigators
University of Minnesota System · USAssociation of Black Cardiologists · USThe University of Texas Southwestern Medical Center · USUniversity of North Carolina at Chapel Hill · USXavier University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe examined whether a fixed dose of both isosorbide dinitrate and hydralazine provides additional benefit in blacks with advanced heart failure, a subgroup previously noted to have a favorable response to this therapy.

methodsA total of 1050 black patients who had New York Heart Association class III or IV heart failure with dilated ventricles were randomly assigned to receive a fixed dose of isosorbide dinitrate plus hydralazine or placebo in addition to standard therapy for heart failure. The primary end point was a composite score made up of weighted values for death from any cause, a first hospitalization for heart failure, and change in the quality of life.

resultsThe study was terminated early owing to a significantly higher mortality rate in the placebo group than in the group given isosorbide dinitrate plus hydralazine (10.2 percent vs. 6.2 percent, P=0.02). The mean primary composite score was significantly better in the group given isosorbide dinitrate plus hydralazine than in the placebo group (-0.1+/-1.9 vs. -0.5+/-2.0, P=0.01; range of possible values, -6 to +2), as were its individual components (43 percent reduction in the rate of death from any cause [hazard ratio, 0.57; P=0.01] 33 percent relative reduction in the rate of first hospitalization for heart failure [16.4 percent vs. 22.4 percent, P=0.001], and an improvement in the quality of life [change in score, -5.6+/-20.6 vs. -2.7+/-21.2, with lower scores indicating better quality of life; P=0.02; range of possible values, 0 to 105]).

conclusionsThe addition of a fixed dose of isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among black patients with advanced heart failure.

Indexed as

Black PeopleAdultAgedDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleHeart FailureHumansHydralazineIsosorbide DinitrateMaleMiddle AgedNitric Oxide DonorsQuality of LifeSurvival AnalysisDrug CombinationsHydralazineIsosorbide DinitrateNitric Oxide DonorsVasodilator Agents

Identifiers

PMID15533851
OpenAlexW2140023412

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.