Evidence map›Paper›PMID 28073769›Full record

ArticleJournal of the American Heart Association2017

Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure.

Reynaria Pitts, Elise Gunzburger, Christie M Ballantyne, Philip J Barter, David Kallend, Lawrence A Leiter, Eran Leitersdorf, Stephen J Nicholls, Prediman K Shah, Jean-Claude Tardif and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Journal of the American Heart Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00658515 (A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT00658515 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2012Enrolled15,871ConditionsCoronary Heart DiseaseArmsDalcetrapib (RO4607381), Evidence-based medical care for Acute Coronary Syndrome, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Reynaria PittsCardiology Section, VA Medical Center and University of Colorado School of Medicine, Denver, CO.
Elise GunzburgerUniversity of Colorado School of Public Health, Aurora, CO.
Christie M BallantyneBaylor College of Medicine, Houston, TX.
Philip J BarterUniversity of New South Wales, Sydney, Australia.
David KallendThe Medicines Company, Zurich, Switzerland.
Lawrence A LeiterDivision of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St Michael's Hospital, University of Toronto, Canada.
Eran LeitersdorfHadassah Hebrew University Medical Center, Jerusalem, Israel.
Stephen J NichollsSouth Australian Health and Medical Research Institute, University of Adelaide, Australia.
Prediman K ShahCedars-Sinai Heart Institute, Los Angeles, CA.
Jean-Claude TardifMontreal Heart Institute, Université de Montréal, Canada.
Anders G OlssonLinköping University, Linköping, Sweden.
John J V McMurrayUniversity of Glasgow, Scotland.
John KittelsonUniversity of Colorado School of Public Health, Aurora, CO.
Gregory G SchwartzCardiology Section, VA Medical Center and University of Colorado School of Medicine, Denver, CO gregory.schwartz@va.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAldosterone may have adverse effects in the myocardium and vasculature. Treatment with an aldosterone antagonist reduces cardiovascular risk in patients with acute myocardial infarction complicated by heart failure (HF) and left ventricular systolic dysfunction. However, most patients with acute coronary syndrome do not have advanced HF. Among such patients, it is unknown whether aldosterone predicts cardiovascular risk. METHODS AND

resultsTo address this question, we examined data from the dal-OUTCOMES trial that compared the cholesteryl ester transfer protein inhibitor dalcetrapib with placebo, beginning 4 to 12 weeks after an index acute coronary syndrome. Patients with New York Heart Association class II (with LVEF <40%), III, or IV HF were excluded. Aldosterone was measured at randomization in 4073 patients. The primary outcome was a composite of coronary heart disease death, nonfatal myocardial infarction, stroke, hospitalization for unstable angina, or resuscitated cardiac arrest. Hospitalization for HF was a secondary endpoint. Over a median follow-up of 37 months, the primary outcome occurred in 366 patients (9.0%), and hospitalization for HF occurred in 72 patients (1.8%). There was no association between aldosterone and either the time to first occurrence of a primary outcome (hazard ratio for doubling of aldosterone 0.92, 95% confidence interval 0.78-1.09, P=0.34) or hospitalization for HF (hazard ratio 1.38, 95% CI 0.96-1.99, P=0.08) in Cox regression models adjusted for covariates.

conclusionsIn patients with recent acute coronary syndrome but without advanced HF, aldosterone does not predict major cardiovascular events. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00658515.

Indexed as

Acute Coronary SyndromeAgedAldosteroneAmidesAngina, UnstableAnticholesteremic AgentsCardiovascular DiseasesCoronary DiseaseEstersFemaleHeart ArrestHeart FailureHospitalizationHumansMaleMiddle AgedAldosteroneAmidesAnticholesteremic AgentsdalcetrapibEstersSulfhydryl Compoundsacute coronary syndromealdosteronemorbidity/mortality

Identifiers

PMID28073769
PMCPMC5523625

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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.