JACC. Heart failure

Study Design and Starting Characteristics of a Trial Testing Semaglutide in Obese Patients with Heart Failure and Preserved Heart Pumping

Updated

Abstract

1,146 participants with heart failure and obesity were randomized in the STEP-HFpEF trials.

  • Nearly half of the participants were women, with a median body mass index of 37 kg/m².
  • Participants exhibited typical HFpEF characteristics, including a median left ventricular ejection fraction of 57% and elevated natriuretic peptides.
  • Most participants were on diuretics and renin-angiotensin blockers, while about one-third were using mineralocorticoid receptor antagonists.
  • Marked impairments were observed, with a Kansas City Cardiomyopathy Questionnaire score around 59 points and a 6-minute walking distance of approximately 300 meters.
  • The trials aim to assess whether semaglutide can improve symptoms, physical limitations, and exercise function alongside weight loss.

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Funding

Competing interests

Funding Support and Author Disclosures The STEP-HFpEF and STEP-HFpEF DM trials were funded by Novo Nordisk. Dr Kosiborod served as a consultant or on an advisory board for 35Pharma, Alnylam, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Janssen, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Pfizer, scPharmaceuticals, Structure Therapeutics, Vifor Pharma, and Youngene Therapeutics; has received research grants from AstraZeneca and Boehringer Ingelheim; holds stocks in Artera Health and Saghmos Therapeutics; has received honorarium from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and has received other research support from AstraZeneca. Dr Abildstrøm is employed by Novo Nordisk; and has shares in Novo Nordisk. Dr Borlaug has received research support from the National Institutes of Health and the United States Department of Defense; has received research grant funding from AstraZeneca, Axon, GlaxoSmithKline, Medtronic, Mesoblast, Novo Nordisk, Rivus, and Tenax Therapeutics; has served as a consultant for Actelion, Amgen, Aria, Axon Therapies, BD, Boehringer Ingelheim, Cytokinetics, Edwards Lifesciences, Eli Lilly, Imbria, Janssen, Merck, Novo Nordisk, NGM, NXT, and VADovations; and is named inventor (U.S. patent number 10,307,179) for the tools and approach for a minimally invasive pericardial modification procedure to treat heart failure. Dr Butler is a consultant to Abbott, American Regent, Amgen, Applied Therapeutic, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiac Dimension, Cardior, CVRx, Cytokinetics, Edwards, Element Science, Innolife, Impulse Dynamics, Imbria, Inventiva, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Roche, Sequana, SQ Innovation, 3live, and Vifor. Dr Christensen is employed by Novo Nordisk; and has shares in Novo Nordisk. Dr Davies has acted as a consultant, advisory board member, and speaker for Boehringer Ingelheim, Lilly, Novo Nordisk, and Sanofi; is an advisory board member and speaker for AstraZeneca; is an advisory board member for Pfizer, Medtronic, and ShouTi Pharma Inc; is a speaker for Novartis, Sanofi, and Amgen; and has received grants in support of investigator and investigator-initiated trials from AstraZeneca, Sanofi-Aventis, Eli Lilly, Boehringer Ingelheim, Janssen, and Novo Nordisk. Dr Hovingh is employed by Novo Nordisk and The Amsterdam University Medical Center; and has shares in Novo Nordisk. Dr Kitzman has served as a paid consultant for Novo Nordisk; and his institution has received grant awards from Novo Nordisk. Dr Lindegaard is employed by Novo Nordisk; and has shares in Novo Nordisk. Dr Møller is employed by Novo Nordisk; and has shares in Novo Nordisk. Dr Shah has been supported by research grants from the National Institutes of Health (U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, and R01 HL149423); and reports receiving consulting fees from Abbott, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer-Ingelheim, Boston Scientific, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, Metabolic Flux, MyoKardia, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and United Therapeutics. Dr Treppendahl is employed by Novo Nordisk; and has shares in Novo Nordisk. Dr Verma has received speaking honoraria and/or consulting fees from Abbott, AstraZeneca, Bayer, Boehringer-Ingelheim, Novo Nordisk, Novartis, Merck, PhaseBio, HLS Therapeutics, Amarin, Eli Lilly, Janssen, Pfizer, TIMI, and Canadian Medical and Surgical Knowledge Translation Research Group. Dr Petrie has received research grants or consultancy fees from SQ Innovations, AstraZeneca, Roche, Boehringer Ingelheim, Pharmacosmos, Eli Lilly, Napp Pharmaceuticals, Novartis, and Novo Nordisk; has served on committees for AbbVie, Akero, Alnylam, AstraZeneca, Bayer, Boehringer Ingelheim, GlaxoSmithKline, Resverlogix, Teikoku, New Amsterdam, and Novo Nordisk; and is director of Global Clinical Trial Partners.
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