Evidence map›Paper›PMID 26903532›Full record

Trial reportEuropean heart journal2016

Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 × 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol.

Geeta Gulati, Siri Lagethon Heck, Anne Hansen Ree, Pavel Hoffmann, Jeanette Schulz-Menger, Morten W Fagerland, Berit Gravdehaug, Florian von Knobelsdorff-Brenkenhoff, Åse Bratland, Tryggve H Storås and 5 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 332 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
332citing papers in PubMed, 17 pooled it
54.3field-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.

NCT03392740 phase4withdrawnnot on this mapstarted 2018, after this paper: background citation

Prophylactic Lisinopril to Prevent Anthracycline Induced Left Ventricular Systolic Dysfunction (PLAID) Study.

TypeinterventionalSponsorAscension HealthRan2018 to 2018Enrolled0ConditionsCardiomyopathy Due to Drug, Heart Failure, SystolicArmsLisinopril, Placebo Oral Tablet
NCT06304896 phase1unknown statusnot on this mapstarted 2024, after this paper: background citation

Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

TypeinterventionalSponsorArab Contractors Medical CentreRan2024 to 2025Enrolled150ConditionsChemotherapy Induced Systolic DysfunctionArmsCarvedilol, Ramipril, Rosuvastatin, Colchicine, Placebo
3 · Its place in the literature

Who cites it

332 citing papers in PubMed, 17 syntheses or guidelines pooled it, 672 citations in OpenAlex.

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  8. Efficacy and safety of cardiac resynchronization therapy in chemotherapy-induced cardiomyopathy: A systematic review.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2023
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  10. Brazilian Society of Cardiology Guideline on Myocarditis - 2022.Arquivos brasileiros de cardiologia · 2022
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272 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 2 countries.

Geeta GulatiDepartment of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Center for Heart Failure Research and K.G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway.
Siri Lagethon HeckDepartment of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Center for Heart Failure Research and K.G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway.
Anne Hansen ReeDepartment of Oncology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Pavel HoffmannDepartment of Cardiology, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway.
Jeanette Schulz-MengerDepartment of Cardiology, Charité Campus Buch, University Medicine Berlin, Berlin, Germany HELIOS Clinics Berlin-Buch, Berlin, Germany.
Morten W FagerlandOslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.
Berit GravdehaugDepartment of Breast and Endocrine Surgery, Division of Surgery, Akershus University Hospital, Lørenskog, Norway.
Florian von Knobelsdorff-BrenkenhoffDepartment of Cardiology, Charité Campus Buch, University Medicine Berlin, Berlin, Germany.
Åse BratlandDepartment of Oncology, Division of Cancer Medicine, Surgery & Transplantation, Oslo University Hospital-Norwegian Radium Hospital, Oslo, Norway.
Tryggve H StoråsIntervention Centre, Oslo University Hospital, Oslo, Norway.
Tor-Arne HagveInstitute of Clinical Medicine, University of Oslo, Oslo, Norway Section for Medical Biochemistry, Division for Diagnostics and Technology, Akershus University Hospital, Lørenskog, Norway.
Helge RøsjøDepartment of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Center for Heart Failure Research and K.G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway.
Kjetil SteineDepartment of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Center for Heart Failure Research and K.G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway.
Jürgen GeislerDepartment of Oncology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Torbjørn OmlandDepartment of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway Center for Heart Failure Research and K.G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway torbjorn.omland@medisin.uio.no.
Akershus University Hospital · NOOslo University Hospital · NOUniversity of Oslo · NOCharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsContemporary adjuvant treatment for early breast cancer is associated with improved survival but at the cost of increased risk of cardiotoxicity and cardiac dysfunction. We tested the hypothesis that concomitant therapy with the angiotensin receptor blocker candesartan or the β-blocker metoprolol will alleviate the decline in left ventricular ejection fraction (LVEF) associated with adjuvant, anthracycline-containing regimens with or without trastuzumab and radiation. METHODS AND

resultsIn a 2 × 2 factorial, randomized, placebo-controlled, double-blind trial, we assigned 130 adult women with early breast cancer and no serious co-morbidity to the angiotensin receptor blocker candesartan cilexetil, the β-blocker metoprolol succinate, or matching placebos in parallel with adjuvant anticancer therapy. The primary outcome measure was change in LVEF by cardiac magnetic resonance imaging. A priori, a change of 5 percentage points was considered clinically important. There was no interaction between candesartan and metoprolol treatments (P = 0.530). The overall decline in LVEF was 2.6 (95% CI 1.5, 3.8) percentage points in the placebo group and 0.8 (95% CI -0.4, 1.9) in the candesartan group in the intention-to-treat analysis (P-value for between-group difference: 0.026). No effect of metoprolol on the overall decline in LVEF was observed.

conclusionIn patients treated for early breast cancer with adjuvant anthracycline-containing regimens with or without trastuzumab and radiation, concomitant treatment with candesartan provides protection against early decline in global left ventricular function.

Indexed as

Adrenergic beta-AntagonistsAngiotensin Receptor AntagonistsAnthracyclinesAntineoplastic AgentsBenzimidazolesBiphenyl CompoundsBreast NeoplasmsChemotherapy, AdjuvantDouble-Blind MethodDrug Therapy, CombinationFemaleHeart FailureHumansMetoprololMiddle AgedTetrazolesAdrenergic beta-AntagonistsAngiotensin Receptor AntagonistsAnthracyclinesAntineoplastic AgentsBenzimidazolesBiphenyl Compoundscandesartan cilexetilMetoprololTetrazolesTrastuzumabAngiotensin antagonistBiomarkersBreast cancerCardiomyopathyImagingβ-Blocker

Identifiers

PMID26903532
PMCPMC4887703
OpenAlexW2298838354

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.