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Article History

Received: 27 February 2023

Accepted: 27 July 2023

First Online: 17 August 2023

Declarations

:

: The design and primary results of the international, multicenter, double-blind, placebo-controlled, phase 4 randomized AFFIRM-AHF trial are published [, ]. The trial was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practice guidelines, and local and national regulations. The protocol was approved by the relevant local Institutional Review Boards/Ethics Committees/Independent Ethics Committees, and all patients provided their written informed consent to participate.

: Not applicable.

: P.P. has received research grants and personal fees from Vifor Pharma (PI of AFFIRM-AHF; participation in clinical trials); and personal fees from Amgen, Bayer, Novartis, Abbott Vascular, Boehringer Ingelheim, Pfizer, Servier, AstraZeneca, Berlin Chemie, Cibiem, BMS, Impulse Dynamics (participation in clinical trials). S.D.A has received grants from Abbott Vascular and Vifor International; and has received personal fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bioventrix, Brahms, Cardiac Dimensions, Cardior, Cordio, CVRx, Edwards, Impulse Dynamics, Janssen, Novartis, Occlutech, Respicardia, Servier, Vectorious, and V-Wave, all outside the submitted work. J.B. has received personal fees from Vifor Pharma, Abbott, Adrenomed, Amgen, Applied Therapeutics, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, G3 Pharma, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana Medical, and V-Wave Limited (consultant). V.F., V.K. and U.M.G^ have received personal fees from Vifor Pharma (Vifor Pharma employee). G.F. has received personal fees from Servier (Lecture and Registry Committee member), personal fees from Novartis (Lecture Fees and Trial/Registry Committee member), and personal fees from Boehringer Ingelheim (Lecture and Trial Committee member). I.C.M has received personal fees for consulting from Vifor Pharma and GlaxoSmithKline and played a leadership/fiduciary role in the ASCEND Trial Steering Committee for GlaxoSmithKline. M.M. has received personal fees from Vifor Pharma (Executive Committee member); Amgen (Executive Committee member and National PI); AstraZeneca, Abbott Vascular, Bayer (participation in advisory boards); Edwards Therapeutics (speeches at sponsored symposia); Actelion (DMC Member); LivaNova (Executive Committee member); and Windtree Therapeutics (Executive Committee member and advisory board). F.R. reports personal fees from Vifor for his role in the Clinical Event Adjudication Committee for Vifor in 2016, during the conduct of the study; F.R. has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years (remuneration for the time spent in activities, such as participation in and steering committee member of clinical trials, were made directly to the University of Zurich); the Department of Cardiology (University Hospital of Zurich/University of Zurich) reports research, educational, and/or travel grants from Abbott, Amgen, AstraZeneca, Bayer, B. Braun, Biosense Webster, Biosensors Europe AG, Biotronik, BMS, Boehringer Ingelheim, Boston Scientific, Bracco, Cardinal Health Switzerland, Daiichi, Diatools AG, Edwards Lifesciences, Guidant Europe NV (BS), Hamilton Health Sciences, Kaneka Corporation, Labormedizinisches Zentrum, Medtronic, MSD, Mundipharma Medical Company, Novartis, Novo Nordisk, Orion, Pfizer, Quintiles Switzerland Sarl, Sanofi, Sarstedt AG, Servier, SIS Medical, SSS International Clinical Research, Terumo Deutschland, V-Wave, Vascular Medical, Vifor, Wissens Plus, and ZOLL; the research and educational grants do not impact F.R.’s personal remuneration. P.v.d.M. has received consultancy fees and/or grants from Vifor (Executive Committee, speaker); Novartis, Pharmacosmos, Astra Zeneca, Pfizer, Pharma Nord, BridgeBio, Novo Nordisk and Ionis. E.A.J. has received research grants and personal fees from Vifor Pharma (co-PI of the AFFIRM trial); and personal fees from Bayer, Novartis, Abbott, Boehringer Ingelheim, Pfizer, Servier, AstraZeneca, Berlin Chemie, Cardiac Dimensions, Fresenius, and Gedeon Richter. C.V., B.A.K. and G.R. declare no competing interests.