Evidence map›Paper›PMID 32215700›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2020

Covariate adjusted reanalysis of the I-Preserve trial.

João Pedro Ferreira, Pooja Dewan, Pardeep S Jhund, Ana Lorenzo-Almorós, Kévin Duarte, Mark C Petrie, Peter E Carson, Robert McKelvie, Michel Komajda, Michael Zile and 2 more

Registry-linked trialOpen access · greenAbstract readClinical TrialComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07429396 (Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 14% 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.

NCT07429396 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction

TypeobservationalSponsorInstituto Politécnico de LeiriaRan2026 to 2028Enrolled200ConditionsHeart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction (HFPEF)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. The four pillars of HFrEF therapy: is it time to treat heart failure regardless of ejection fraction?European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  5. Article
  6. Review
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

12 authors at 8 institutions in 5 countries.

João Pedro FerreiraBHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.
Pooja DewanBHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.
Pardeep S JhundBHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.
Ana Lorenzo-AlmorósDepartment of Internal Medicine. Renal, Vascular and Diabetes Laboratory, Instituto de Investigaciones Sanitarias Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid, Spain.
Kévin DuarteNational Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.
Mark C PetrieBHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.
Peter E CarsonCardiovascular Division, Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC, USA.
Robert McKelvieDepartment of Medicine, Western University, London, ON, Canada.
Michel KomajdaService de Cardiologie, Hôpital Saint Joseph, Paris, France.
Michael ZileMedical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina, USA.
Faiez ZannadNational Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.
John J V McMurrayBHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK. john.mcmurray@glasgow.ac.uk.
University of Glasgow · GBDéfaillance Cardiovasculaire Aiguë et ChroniqueHôpital Paris Saint-Joseph · FRInserm · FRMedical University of South Carolina · USUniversidad Autónoma de Madrid · ESVeterans Health Administration · USWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe CHARM-Preserved trial suggested that the renin-angiotensin system (RAS) inhibitor candesartan might have been beneficial in heart failure with preserved ejection fraction (HFpEF); however, this hypothesis was not supported by the findings of I-Preserve with irbesartan.

aimsTo re-analyse the results of I-Preserve, adjusting for imbalances in baseline variables that may have influenced the trial outcomes.

methodsCox proportional hazards models with covariate adjustment for baseline variables, including age, sex, medical history, physiological and laboratory variables.

resultsIn I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). The prespecified analysis of this outcome, stratifying for the use of ACEi at baseline, gave a hazard ratio (HR) of 0.95 (95% confidence interval, 0.86-1.05); p = 0.35. Adjusting the effect of treatment for key prognostic baseline variables, gave a HR of 0.89 (0.80-0.99); p = 0.033. Similar findings were observed for the composite of cardiovascular death or HF hospitalization.

conclusionAdjusting for imbalances in baseline variables that influence outcomes (or the response to therapy or both) can improve the power around the estimate of the effect of treatment and may alter its statistical significance. Along with the CHARM-Preserved results, these findings suggest that angiotensin-receptor blockers may have a modest effect in HFpEF.

Indexed as

AgedAngiotensin II Type 1 Receptor BlockersAngiotensin Receptor AntagonistsFemaleHeart FailureHospitalizationHumansMaleMiddle AgedPrognosisStroke VolumeAngiotensin II Type 1 Receptor BlockersAngiotensin Receptor AntagonistsCovariate adjustmentHeart failure with preserved ejection fractionIrbesartanTreatment effects

Identifiers

PMID32215700
OpenAlexW3013393618

What OpenQuestion holds

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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.