Trial reportJACC. Heart failure2025

Semaglutide and Exercise Function in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.

Barry A Borlaug, Dalane W Kitzman, Shachi Patel, Khaja M Chinnakondepalli, Javed Butler, Melanie J Davies, Mark C Petrie, Sanjiv J Shah, Subodh Verma, Julio Núñez and 5 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in JACC. Heart failure, 2025. The graph read 2 numbers from its abstract, feeding 1 cell of the map, but it casts no vote: it is a later paper about NCT04788511, whose primary report (PMID 37622681) speaks for the trial. It reports registered trial NCT04788511. Cited by 5 papers.

2numbers the graph read from it
0cells of the map it votes in
5citing 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.

← favours the comparatorfavours the treatment →
25.00 · no effect
6-minute walk distance (6MWD)semaglutide vs placebofavours the treatment · heart_failure, obesityfeeds one cell of the map
Δ 14.68.60 to 20.7< 0.0001
Treatment with semaglutide increased 6MWD compared with placebo, an effect apparent at 20 weeks (treatment difference 14.6 m [95% CI: 8.6-20.7 m]; P < 0.0001) that was maintained at 52 weeks (treatment difference 17.1 m [95% CI: 9.2-25.0 m]; P < 0.0001).
6-minute walk distance (6MWD)semaglutide vs placebofavours the treatment · heart_failure, obesityfeeds one cell of the map
Δ 17.19.20 to 25.0< 0.0001
Treatment with semaglutide increased 6MWD compared with placebo, an effect apparent at 20 weeks (treatment difference 14.6 m [95% CI: 8.6-20.7 m]; P < 0.0001) that was maintained at 52 weeks (treatment difference 17.1 m [95% CI: 9.2-25.0 m]; P < 0.0001).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

GLP-1 receptor agonists×cardiac & vascular function

Does not voteOpen on the map →What to test next →

6 readable studies in this cell: 3 favour the treatment, 2 find no difference, 1 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 1 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
This paper’s trial, registry resultNCT04788511 · 529 enrolled · 2021
Δ 7.804.80 to 10.9
Δ 7.304.10 to 10.4
NCT0488111060 enrolled · 2021
Δ 25.121.8 to 28.3
4 · 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.

NCT04788511 phase3completed

Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction

Ran2021Enrolled529Registered outcomes15Posted comparisons2ConditionsObesityArmsPlacebo (semaglutide), semaglutide
PMID 37622681PMID 37635157other papers from this trial
Open the trial in the graph
NCT04916470 phase3completed

Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes

Ran2021Enrolled617Registered outcomes23Posted comparisons0ConditionsHeart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2ArmsPlacebo (semaglutide), semaglutide
PMID 37294245other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Obesity and Heart Failure: Introducing the Theme.Journal of cardiovascular development and disease · 2026
    Review
  5. Review
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

15 authors.

Barry A BorlaugDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. Electronic address: borlaug.barry@mayo.edu.
Dalane W KitzmanDepartment of Internal Medicine, Sections on Cardiovascular Medicine and Geriatrics/Gerontology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Shachi PatelSaint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
Khaja M ChinnakondepalliSaint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
Javed ButlerBaylor Scott and White Research Institute, Dallas, Texas, USA, and University of Mississippi, Jackson, Mississippi, USA.
Melanie J DaviesDiabetes Research Centre, University of Leicester, Leicester, UK, and NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom.
Mark C PetrieSchool of Cardiovascular & Metabolic Health, University of Glasgow, Glasgow, United Kingdom.
Sanjiv J ShahDivision of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Subodh VermaDivision of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, ON, Canada.
Julio NúñezHospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, Valencia, Spain; and CIBER Cardiovascular, Valencia, Spain.
Mette Nygaard EinfeldtNovo Nordisk A/S, Søborg, Denmark.
Karoline LiisbergNovo Nordisk A/S, Søborg, Denmark.
Afshin SalsaliNovo Nordisk A/S, Søborg, Denmark.
Mikhail N KosiborodDepartment of Cardiovascular Disease, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA.
STEP-HFpEF Trial Committees and Investigators

Funding

Wake Forest Claude D. Pepper OAIC - RenewalP30AG021332 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI STEPHEN B. KRITCHEVSKY · 2002 to 2026
$36.4M
Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF TrialR01AG078153 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KITZMAN, DALANE W · 2022 to 2025
$26.6M
HeartShare DeCODE-HF: Data translation center to Combine Omics, Deep phenotyping, and Electronic health records for Heart Failure subtypes and treatment targetsU54HL160273 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Abel N. Kho, Yuan Luo · 2021 to 2026
$19.0M
REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure PatientsR01AG045551 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KITZMAN, DALANE W · 2014 to 2018
$6.8M
Transition from Risk Factors to Early HF: Prevalence, Pathogenesis, and PhenomicsR01HL127028 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BERTONI, ALAIN GERALD, SHAH, SANJIV J · 2015 to 2018
$6.5M
Pepper OAIC Coordinating CenterU24AG059624 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI DALANE W KITZMAN · 2018 to 2026
$6.0M
Exercise Intolerance in Older HFPEF PatientsR01AG018915 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KITZMAN, DALANE W · 2001 to 2019
$5.2M
Study of Cardiac Mechanics in Systemic HypertensionR01HL107577 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SHAH, SANJIV J · 2011 to 2019
$4.1M
Pulmonary Hypertension in Left Heart DiseaseR01HL162828 · NHLBI · MAYO CLINIC ROCHESTER · PI Barry A. Borlaug, Margaret M Redfield · 2023 to 2026
$3.1M
Machine learning for the automated identification and tracking of rare myocardial diseasesR01HL140731 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MACRAE, CALUM A., SHAH, SANJIV J · 2018 to 2021
$2.8M
HL-Inorganic Nitrite to Enhance Benefits from Exercise Training in Heart Failure with preserved Ejection FractionR01HL128526 · NHLBI · MAYO CLINIC ROCHESTER · PI BORLAUG, BARRY A. · 2016 to 2019
$2.4M
Wake Forest Atrium HeartShare Clinical CenterU01HL160272 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI DALANE W KITZMAN · 2021 to 2026
$2.3M
NHLBI NIH HHS R01 HL107577NHLBI NIH HHS R01 HL127028NHLBI NIH HHS R01 HL128526NHLBI NIH HHS R01 HL140731NHLBI NIH HHS R01 HL149423NHLBI NIH HHS R01 HL162828NHLBI NIH HHS U01 HL160226NHLBI NIH HHS U01 HL160272NHLBI NIH HHS U54 HL160273NIA NIH HHS P30 AG021332NIA NIH HHS R01 AG018915NIA NIH HHS R01 AG045551NIA NIH HHS R01 AG078153NIA NIH HHS U01 AG076928NIA NIH HHS U24 AG059624
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundExercise function quantified by 6-minute walk distance (6MWD) is severely impaired in patients with heart failure with preserved ejection fraction (HFpEF).

objectivesThis prespecified secondary analysis of pooled data from the STEP-HFpEF Program (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity) examined factors associated with impaired exercise function at baseline, detailed effects of semaglutide on 6MWD, and on other key trial endpoints according to baseline 6MWD in patients with HFpEF.

methodsAssociates of 6MWD were assessed at baseline, and effects of semaglutide on 6MWD were evaluated at early (20 weeks) and final (52 weeks) time points, across subgroups, and according to the magnitude of weight loss achieved. Effects of semaglutide on the dual primary (changes in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score [KCCQ-CSS] and body weight) and secondary/exploratory endpoints were contrasted by tertiles of baseline 6MWD.

resultsThe authors randomized 1,145 patients to semaglutide or placebo. Compared with patients who had obesity-related HFpEF and higher 6MWD, those with lower 6MWD were older and had lower KCCQ-CSS, higher body mass index and waist circumference, greater systemic inflammation (higher C-reactive protein), and more severe congestion (higher N-terminal pro-B-type natriuretic peptide, more diuretic use). Treatment with semaglutide increased 6MWD compared with placebo, an effect apparent at 20 weeks (treatment difference 14.6 m [95% CI: 8.6-20.7 m]; P < 0.0001) that was maintained at 52 weeks (treatment difference 17.1 m [95% CI: 9.2-25.0 m]; P < 0.0001). Increases in 6MWD with semaglutide (vs placebo) were similar across all relevant subgroups, with no significant interactions. Treatment with semaglutide increased KCCQ-CSS and reduced body weight, reduced C-reactive protein, improved the hierarchical composite (death, heart failure events, change in KCCQ-CSS and 6MWD), and reduced N-terminal pro-B-type natriuretic peptide across the spectrum of baseline 6MWD (all P

conclusionsIn patients with obesity-related HFpEF, impaired 6MWD is most strongly associated with excess adiposity, congestion, and inflammation. Semaglutide-mediated improvements in HF-related symptoms, physical limitations, and exercise function were consistent across the spectrum of baseline 6MWD, observed as early as 20 weeks after the initiation of treatment, preceding maximal weight loss. The effects were consistent across subgroups. There was strong correlation between greater magnitude of weight loss and greater improvements in 6MWD. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF], NCT04788511; Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes [STEP-HFpEF DM], NCT04916470).

Indexed as

Exercise ToleranceGlucagon-Like PeptidesHeart FailureObesityStroke VolumeAgedDouble-Blind MethodFemaleGlucagon-Like Peptide 1HumansMaleMiddle AgedSemaglutideWalk TestWeight LossGlucagon-Like Peptide 1Glucagon-Like PeptidesSemaglutide6-minute walk distanceheart failure with preserved ejection fractionobesitysemaglutide

Identifiers

PMID41045908
PMCPMC12688318

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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.