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Review
. 2025 Aug:286:18-34.
doi: 10.1016/j.ahj.2025.03.005. Epub 2025 Mar 17.

Advancement of the implementation of evidence-based therapies for cardiovascular-kidney-metabolic conditions: A multi-stakeholder perspective

Nkiru Osude  1 , Harriette Van Spall  2 , Hayden Bosworth  3 , Konstantin Krychtiuk  4 , John Spertus  5 , Samuel Fatoba  6 , Lee Fleisher  7 , Edward Fry  8 , Jennifer Green  9 , Stephen Greene  9 , Michael Ho  10 , Jennifer Jackman  11 , Jane Leopold  12 , Melissa Magwire  13 , Darren McGuire  14 , George Mensah  15 , Katherine R Tuttle  16 , Vincent Willey  17 , Neha Pagidipati  11 , Christopher Granger  9
Affiliations
Review

Advancement of the implementation of evidence-based therapies for cardiovascular-kidney-metabolic conditions: A multi-stakeholder perspective

Nkiru Osude et al. Am Heart J. 2025 Aug.

Abstract

Cardiovascular disease remains the leading cause of mortality and healthcare expenditures in the United States. It is also a major contributor to premature mortality, years lived with disability, and rising healthcare costs around the world. Despite the availability of proven therapies and interventions that could vastly decrease the burden of cardiovascular disease and cardiometabolic conditions, their implementation is poor, with generally less than half of patients being treated with the most effective therapies. Implementation science offers promise in bridging this gap and mitigating disparities. However, even though small studies have shown that there are effective methods to improve the implementation of evidence-based therapies, these methods have not been scaled to make an impact at the level of health systems or nationally. A coordinated, multi-stakeholder approach is essential to identify barriers to implementation on a broad scale and, more critically, to develop and deploy practical solutions. The Duke Clinical Research Institute conducted an Implementation Summit entitled "Scalability, Spread, and Sustainability" to explore strategies for advancing the uptake of evidence-based interventions for cardiometabolic diseases in healthcare in the United States. This manuscript presents the participants' multi-stakeholder perspective on the steps necessary to improve the implementation of evidence-based therapies in cardiometabolic disease. Key recommendations include focused efforts on evidence generation around broad implementation strategies, dissemination of the evidence generated, uptake of evidence into usual care settings, and investment in training the current and next generations of leaders in implementation.

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Conflict of interest statement

Declaration of competing interest Hayden Bosworth received funds from Duke University for travel to the Summit meeting; grants paid to his institution (not related to the reported work) from BeBetter Therapeutics, Boehringer Ingelheim, Esperion, Merck, Improved Patient Outcomes, National Institutes of Health, Novo Nordisk, Otsuka, Elton John Foundation, Sanofi, Pfizer, Veteran Health Administration, and Hilton Foundation; and consulting fees (not related to the reported work) from Webmed, Walmart, Imatar, Sanofi, and Boehringer Ingelheim. He was previously a member of the Board of Directors of Preventic Diagnostics. Samual Fatoba was an employee of Bayer LLC at the time of the meeting and manuscript preparation. Lee Fleisher worked as the Founding Principal of Rubrum Advising, which advises medical device companies on coverage, but there is no specific conflict with any of the technologies discussed in the manuscript.He was previously CMS, CMO, and Director of the Center for Clinical Standards and Quality. Edward Fry participated on a Data Safety Monitoring Board for Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T Trial) DSMB 2021-2023, served as President of the American College of Cardiology (2022-2023), and was a board member of the American Board of Cardiovascular Medicine (2024-present). Christopher Granger has consulted for Abbvie, Abiomed, Alnylam Pharmaceuticals, Amgen, Anthos, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardionomic, CeleCore Therapueutics, HengRui, Janssen, Lilly, Medscape, Medtronic Inc., Merck, NIH, Novo Nordisk, NephroSynergy, Novartis, Pfizer, Philips, REATA, Roche, and Veralox; has received research grant support from Alnylam, Boehringer Ingelheim, Bristol Myers Squibb, FDA, Janssen, Lilly, Novartis, Pfizer, Philips, and Roche; and has equity in Tenac.io. Jennifer Green received funds from Duke University to support travel to the Summit meeting; funds paid to her institution for the conduct of clinical research from Merck, Roche, Boehringer Ingelheim, Lilly, and Bluedrop; and consulting fees related to the management of diabetes, obesity, and/or kidney disease from AstraZeneca, Novo Nordisk, Pfizer, Bayer, Anji, Boehringer Ingelheim, Valo, Lilly, Verte, Mineralys, and Corcept. Stephen Greene received grants or contracts from AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, CSL Vifor, Novartis, Otsuka, and Sanofi; consulting fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Cytokinetcs, Boehringer Ingelheim, PharmaIN, Sanofi, Tricog Health, Corteria Therapeutics, Roche Diagnostics, Sumitomo, CSL Vifor, Novo Nordisk, Otsuka, Lexicon, and Corcept; and payment or honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Leicon, and Roche Diagnostics. Michael Ho reports no conflicts of interest. Jennifer Jackman reports no conflicts of interest. Konstantin Krychtiuk received consulting fees from Novartis, Amarin, and Sanofi; payment or honoraria from Daiichi Sankyo, Amaran, and Zoll Medical; and support for travel from Amgen and Daiichi Sankyo. He was a board member of the European Society of Cardiology Association for Acute Cardiovascular Care. Jane Leopold was the deputy editor of the New England Journal of Medicine. Melissa Magwire has received consulting fees paid to herself from Novo Nordisk, Boehringer Ingelheim, and Eli Lilly and consulting fees paid to her institution from Amgen. Darren McGuire has received consulting fees from Novo Nordisk, AstraZeneca, Pfizer, Altimmune, Ventyx Pharmaceuticals, Bayer, Lexicon, Applied Therapeutics, Intercept Pharmaceuticals, Esperion, Lilly USA, Boehringer Ingelheim, New Amsterdam, CSL Behring, Amgen, Neutronics, Metsera Pharma, Kailera, and Alveus Pharma. George Mensah reports no conflicts of interest. Nkiru Osude received support for the manuscript from the National Institutes of Health award number T32HL069749. Neha Pagidipati has received research support from Alnylam, Amgen, Bayer, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, and Merck; has served on consultation/advisory panels for Amgen, Bayer, Boehringer Ingelheim, Corcept, Corsera, Eli Lilly, Esperion, AstraZeneca, Merck, New Amsterdam, Novartis, and Novo Nordisk; has been executive committee member for phase 4 trials sponsored by Novo Nordisk and Novartis and for phase 2/3 registration trials sponsored by Alnylam, AstraZeneca, and Amgen; has served on data safety monitoring board for trials sponsored by Johnson and Johnson and Novartis; and has served on a medical advisory board for Miga Health. John Spertus received funds from Duke University for travel to the Summit meeting; funds paid to his institution from Janssen, Imbria, and Lexicon for the conduct of his clinical research; license fees for the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and consulting fees from Alnylam, AstraZeneca, Bayer, Janssen, Bristol Meyers Squibb, Terumo, Cytokinetics, BridgeBio, VentricHealth, and Imbria. He was a RECOVER Data Safety Monitoring Board Member for the National Heart, Lung, and Blood Institute (NHLBI), and he was a member of the Board of Directors of Blue Cross Blue Shield of Kansas City. Katherine Tuttle received grants paid to her institution from the National Institutes of Health (R01MD014712, U2CDK114886, UL1TR002319, U54DK083912, U01DK100846, OT2HL161847, UM1AI109568, OT2OD032581), Travere Therapeutics, Bayer, Doris Duke Charitable Foundation, Centers for Disease Control and Prevention, and Benaroya Research Institute; consulting fees from AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Travere Therapeutics; and payment or honoraria from Novo Nordisk. She was the chair of Data Safety Monitoring Boards for the National Institute of Diabetes and Digestive and Kidney Diseases and George Clinical Institute, and she was a member of a Data Safety Monitoring Board for AstraZeneca. She was the chair of the Diabetic Kidney Disease Collaborative, American Society of Nephrology, and Kidney Week 2025 Program Committee, and member of the American Heart Association/American College of Cardiology Cardiovascular-Kidney-Metabolic Guideline Committee. Harriette Van Spall received grants or contracts from Boehringer Ingelheim Pharmaceuticals, Inc, Novartis Corporation, the Canadian Institutes of Health Research, and the Heart and Stroke Foundation of Canada; consulting fees from Baim Institute for Clinical Research and Medtronic. She has other interests in Bayer (advisory board), CardioVascular Research Foundation (Clinical Trials Events Committee), Colorado Prevention Center Clinical Research (Clinical Trial Executive Committee), and Medtronic (Clinical Trial Executive Committee). Vincent Willey is employed by Carelon Research, which has received funding from multiple life science companies to perform research studies evaluating topics in the cardiovascular-kidney-metabolic therapeutic area.