Corresponding Author: Paul W. Armstrong, MD, 4-120 Katz Group Centre for Pharmacy and Health Research, University of Alberta, Edmonton, AB T6G 2E1, Canada (paul.armstrong@ualberta.ca).
Accepted for Publication: August 6, 2020.
Correction: This article was corrected for errors in figure labeling on February 2, 2021.
Author Contributions: Dr Armstrong had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Armstrong, Lam, Anstrom, Ezekowitz, Hernandez, O’Connor, Pieske, Ponikowski, Shah, Solomon, Voors, Vlajnic, Carvalho, Bamber, Blaustein, Roessig, Butler.
Acquisition, analysis, or interpretation of data: Armstrong, Lam, Anstrom, Ezekowitz, Hernandez, O’Connor, Pieske, Ponikowski, Voors, She, Vlajnic, Carvalho, Bamber, Blaustein, Roessig, Butler.
Drafting of the manuscript: Armstrong, Lam, Anstrom, Ezekowitz, She, Vlajnic, Roessig, Butler.
Critical revision of the manuscript for important intellectual content: Armstrong, Lam, Anstrom, Ezekowitz, Hernandez, O’Connor, Pieske, Ponikowski, Shah, Solomon, Voors, Vlajnic, Carvalho, Bamber, Blaustein, Roessig, Butler.
Statistical analysis: Armstrong, Anstrom, She, Vlajnic, Bamber.
Obtained funding: Armstrong, Blaustein.
Administrative, technical, or material support: Carvalho, Bamber, Butler.
Supervision: Armstrong, Anstrom, O’Connor, Pieske, Ponikowski, Bamber, Blaustein, Roessig, Butler.
Conflict of Interest Disclosures: Dr Armstrong reported receiving personal fees from Merck and Bayer during the conduct of the study as well as grants from Sanofi-Aventis Recherche & Developpement, Boehringer Ingelheim, and CSL Limited and personal fees from AstraZeneca and Novartis. Dr Lam reported receiving personal fees from Bayer during the conduct of the study as well as grants from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma and personal fees from Abbott Diagnostics, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Biofourmis, Boehringer Ingelheim, Boston Scientific, Corvia Medical, Cytokinetics, Darma, Eko.ai, JanaCare, Janssen Research & Development, Medtronic, Menarini Group, Merck, MyoKardia, Novartis, Novo Nordisk, Radcliffe Group, Roche Diagnostics, Stealth BioTherapeutics, The Corpus, Vifor Pharma, and WebMD. In addition, Dr Lam has a patent pending on a method for diagnosis and prognosis of chronic heart failure (PCT/SG2016/050217) and a patent issued for a clinical workflow that recognizes and analyses 2D and Doppler echocardiogram images for automated cardiac measurements and diagnosis, prediction, and prognosis of heart disease (16/216,929). Dr Lam is also cofounder and nonexecutive director of EKo.ai Pte Ltd. Dr Ezekowitz reported receiving personal fees from Bayer and Merck during the conduct of the study as well as grants and personal fees from American Regent, Novartis, AstraZeneca, Boehringer Ingelheim, Amgen, and Cytokinetics (additional disclosures available online at https://thecvc.ca). Dr Hernandez reported receiving personal fees from Bayer and Merck during the conduct of the study as well as grants and personal fees from AstraZeneca and Novartis and personal fees from Amgen and Cytokinetics. Dr O’Connor reported receiving consulting for Bayer, Bristol Myers Squibb Foundation, and Dey. Dr Pieske reported receiving personal fees from Merck and Bayer during the conduct of the study as well as personal fees from Novartis, Servier, Medscape, and Bristol Myers Squibb. Dr Ponikowski reported receiving personal fees from Merck during the conduct of the study as well as receiving personal fees from and participating in clinical trials for Amgen, Boehringer Ingelheim, Servier, AstraZeneca, RenalGuardSolution, and Cibiem; receiving grants and personal fees from and participating in clinical trials for Vifor Pharma; and receiving personal fees from Pfizer and Respicardia. Dr Shah reported receiving personal fees from Bayer during the conduct of the study as well as grants and personal fees from Actelion, AstraZeneca, Novartis, and Pfizer; grants from Corvia; and personal fees from Cyclerion, Amgen, Boehringer Ingelheim, Cardiora, Cytokinetics, MyoKardia, Merck, Shifamed, Eisai, Ionis, Novo Nordisk, Sanofi, and Tenax. Dr Solomon reported receiving personal fees from Bayer during the conduct of the study as well as grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, Bristol Myers Squibb, Celladon, Cytokinetics, Eidos, Gilead, GlaxoSmithKline, Ionis, Lone Star Heart, Mesoblast, MyoKardia, Neurotronik, the National Institutes of Health/National Heart, Lung, and Blood Institute, Novartis, Respicardia, Sanofi Pasteur, and Theracos and personal fees from Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Bristol Myers Squibb, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi-Sankyo, Gilead, GlaxoSmithKline, Ironwood, Merck, MyoKardia, Novartis, Roche, Takeda, Theracos, Quantum Genetics, Cardurion, AoBiome, Janssen, Cardiac Dimensions, Sanofi Pasteur, Tenaya, Dinaqor, Tremeau, CellProThera, and Moderna. Dr Voors reported receiving personal fees from Merck and Bayer during the conduct of the study as well as personal fees from AstraZeneca, Cytokinetics, Novartis, and MyoKardia and grants and personal fees from Boehringer Ingelheim, Novo Nordisk, and Roche Diagnostics. Ms Vlajnic is an employee of Bayer. Dr Carvalho is an employee of Bayer. Mr Bamber is an employee of Bayer. Dr Blaustein reported receiving personal fees from Merck during the conduct of the study and is an employee of Merck. Dr Roessig is an employee of Bayer. Dr Butler reported receiving personal fees from Bayer and Merck during the conduct of the study as well as personal fees from Abbott, Adrenomed, Amgen, Applied Therapeutics, Array, AstraZeneca, BerlinCures, Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Limited, and Vifor. No other disclosures were reported.
Funding/Support: Funding for this research was provided by Bayer and Merck Sharp & Dohme Corp, a subsidiary of Merck & Co Inc.
Role of the Funder/Sponsor: The sponsors, in collaboration with the steering committee, participated in the design and conduct of the study and the collection, management, analysis, and interpretation of the data. Preparation, review, and approval of the manuscript and the decision to submit the manuscript for publication were undertaken by the steering committee. The sponsors did not have the right to veto publication or to control the decision regarding the choice of journal for submission.
Group Information: The members of the VITALITY-HFpEF Study Group are listed in eAppendix 1 in Supplement 3.
Data Sharing Statement: See Supplement 4.
Additional Contributions: Elizabeth E. S. Cook, BA, an employee of the Duke Clinical Research Institute, and Cecilia Freitas, MD, MSc, PhD, an employee of Bayer, provided editorial assistance. No compensation outside of their regular salaries was received.
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