Evidence map›Paper›PMID 40884047›Full record

Trial reportCirculation2025

Sacubitril/Valsartan and Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: The PRADA II Randomized Clinical Trial.

Torbjørn Omland, Siri Lagethon Heck, Espen Holte, Albulena Mecinaj Lilleaasen, Mari Nordbø Gynnild, Morten Wang Fagerland, Victoria Vinje-Jakobsen, Anne-Katrine Lislegaard Næs, Egil Støre Blix, Alf Inge Larsen and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03760588 (PRevention of cArdiac Dysfunction During Adjuvant Breast Cancer Therapy), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

NCT03760588 phase2completednot on this map

PRevention of cArdiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, Multicenter Trial

TypeinterventionalSponsorTorbjorn OmlandRan2019 to 2024Enrolled138ConditionsBreast Cancer Female, Heart FailureArmsSacubitril/valsartan
3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Risk-guided cardioprotection in cardio-oncology.Nature cardiovascular research · 2026
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  6. Recent updates and perspectives in "Onco-hypertension".Hypertension research : official journal of the Japanese Society of Hypertension · 2026
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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

13 authors.

Torbjørn OmlandK.G. Jebsen Centre for Cardiac Biomarkers, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway (T.O., S.L.H., M.N.G., V.V.-J., G.G.).ORCID 0000-0002-6452-0369
Siri Lagethon HeckK.G. Jebsen Centre for Cardiac Biomarkers, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway (T.O., S.L.H., M.N.G., V.V.-J., G.G.).ORCID 0000-0002-5430-1613
Espen HolteDepartments of Circulation and Medical Imaging (E.H.), NTNU-Norwegian University of Science and Technology, Trondheim, Norway.
Albulena Mecinaj LilleaasenDepartments of Cardiology (T.O., A.M.L., V.V.-J.), Akershus University Hospital, Lørenskog, Norway.
Mari Nordbø GynnildK.G. Jebsen Centre for Cardiac Biomarkers, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway (T.O., S.L.H., M.N.G., V.V.-J., G.G.).ORCID 0000-0001-8623-7911
Morten Wang FagerlandOslo Center for Biostatistics and Epidemiology, Research Support Services (M.W.F.), Oslo University Hospital, Norway.ORCID 0000-0003-4535-5043
Victoria Vinje-JakobsenK.G. Jebsen Centre for Cardiac Biomarkers, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway (T.O., S.L.H., M.N.G., V.V.-J., G.G.).
Anne-Katrine Lislegaard NæsSurgery (A.-K.L.N.), St. Olavs Hospital, Trondheim, Norway.
Egil Støre BlixDepartment of Oncology, University Hospital of North Norway, Tromsø, Norway (E.S.B.).
Alf Inge LarsenDepartment of Cardiology, Stavanger University Hospital, Stavanger, Norway (A.I.L.).ORCID 0000-0002-9141-0499
Jürgen GeislerOncology (J.G.), Akershus University Hospital, Lørenskog, Norway.ORCID 0000-0001-6239-3856
Geeta Gulati *K.G. Jebsen Centre for Cardiac Biomarkers, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway (T.O., S.L.H., M.N.G., V.V.-J., G.G.).ORCID 0000-0002-1316-8676
Torgeir Wethal *Neuromedicine and Movement Science (T.W.), NTNU-Norwegian University of Science and Technology, Trondheim, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnthracycline- and trastuzumab-associated cardiotoxicity may lead to cardiac dysfunction and dose reduction or halt of potentially life-saving adjuvant cancer therapy. Whether angiotensin receptor/neprilysin inhibitors can prevent cancer therapy-related cardiac dysfunction and injury remains to be established.

methodsPRADA II (Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy) was a randomized, parallel-group, placebo-controlled, double-blind, multicenter trial conducted at 4 academic medical centers in Norway that evaluated the cardioprotective effect of sacubitril/valsartan versus placebo administered concomitantly with anthracycline-containing breast cancer therapy and continued for 18 months. The target dose was 97/103 mg BID. The primary outcome was change in left ventricular ejection fraction by cardiovascular magnetic resonance from prior to initiation of chemotherapy to 18 months thereafter. Secondary outcomes included change in echocardiographic global longitudinal strain, circulating cardiac troponins, and NT-proBNP (N-terminal pro-B-type natriuretic peptide).

resultsIn total, 138 women (mean±SD age: 54.0±9.4 years) were randomized. The overall decline in left ventricular ejection fraction from baseline to 18 months was 2.2 percentage points (95% CI, 1.1 to 3.3) in the placebo group and 1.1 percentage points (95% CI, -0.01 to 2.2) in the sacubitril/valsartan group. The between-group difference was 1.1 percentage points (95% CI, -0.4 to 2.7;

conclusionsAnthracycline-based treatment for early breast cancer was associated with a reduction in left ventricular ejection fraction that was not significantly attenuated by sacubitril/valsartan. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03760588.

Indexed as

AminobutyratesAngiotensin Receptor AntagonistsBreast NeoplasmsHeart DiseasesTetrazolesValsartanAdultAnthracyclinesBiphenyl CompoundsCardiotoxicityChemotherapy, AdjuvantDouble-Blind MethodDrug CombinationsFemaleHumansMiddle AgedAminobutyratesAngiotensin Receptor AntagonistsAnthracyclinesBiphenyl CompoundsDrug CombinationsNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)sacubitril and valsartan sodium hydrate drug combinationTetrazolesTrastuzumabValsartananthracyclinesbreast cancercardiotoxicityglobal longitudinal strainmagnetic resonance imagingtroponinventricular ejection fraction

Identifiers

PMID40884047
PMCPMC12537036

What OpenQuestion holds

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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.