@article{cb73bc253b4444e89f95c0995311aaf3,
title = "Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium",
abstract = "The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world's leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.",
keywords = "clinical trials, hypertension, outcomes, renal denervation",
author = "Kandzari, {David E.} and Felix Mahfoud and Weber, {Michael A.} and Raymond Townsend and Gianfranco Parati and Fisher, {Naomi D.L.} and Lobo, {Melvin D.} and Michael Bloch and Michael B{\"o}hm and Sharp, {Andrew S.P.} and Schmieder, {Roland E.} and Michel Azizi and Schlaich, {Markus P.} and Vasilios Papademetriou and Kirtane, {Ajay J.} and Joost Daemen and Atul Pathak and Christian Ukena and Philipp Lurz and Guido Grassi and Martin Myers and Finn, {Aloke V.} and Morice, {Marie Claude} and Roxana Mehran and Peter J{\"u}ni and Stone, {Gregg W.} and Krucoff, {Mitchell W.} and Whelton, {Paul K.} and Konstantinos Tsioufis and Cutlip, {Donald E.} and Ernest Spitzer",
note = "Funding Information: HARC was funded through grants from Medtronic, ReCor Medical, Boston Scientific, BackBeat Medical, Ablative Solutions, Vascular Dynamics, and Metavention. Funding Information: Dr Kandzari reports institutional research/grant support from Ablative Solutions and Medtronic; and personal consulting honoraria from Medtronic. Dr Mahfoud receives research support from the Deutsche Gesellschaft f{\"u}r Kardiologie and Deutsche Forschungsgemeinschaft and has received scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, and ReCor Medical. Dr Weber reports consulting honoraria from Urovant, Johnson & Johnson, Ablative Solutions, Regeneron, Medtronic, Omron, and ReCor Medical. Dr Townsend receives consultant honoraria from Medtronic and Regeneron and royalties from UpToDate and is a data and safety monitoring member at AXIO. Dr Parati declares speaking honoraria from Omron Healthcare, Servier, and Novartis. Dr Fisher receives consultant and research funding from Recor Medical and consulting honoraria from Medtronic and Aktiia. Dr Lobo receives consulting honoraria from Medtronic, ReCor Medical, Ablative Solutions, CVRx, Rox Medical, and Vascular Dynamics and reports educational grants from Medtronic and ReCor Medical. Dr Bloch reports consulting honoraria from Recor and Medtronic. Dr B{\"o}hm reports research support from the Deutsche Forschungsgemeinschaft and reports personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Daiichii-Sankyo, Medtronic, Novartis, ReCor, Servier, and Vifor. Dr Azizi receives research grants from the French Ministry of Health, Quantum Genomics, and the European Horizon 2020 program; grant support and nonfinancial support from ReCor Medical and Idorsia; and personal fees from CVRx, AstraZeneca, Alnylam Pharmaceutical, and Poxel Pharma. Dr Schlaich receives research supported from the NHMRC Research Fellowship and has received consulting fees or travel and research support from Medtronic, Abbott, Otsuka, Novartis, Servier, Pfizer, and Boehringer Ingelheim. Dr Kirtane reports institutional funding to Columbia University or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Siemens, Philips, ReCor Medical, Neurotronic, and Biotronik. In addition to research grants, institutional funding includes fees paid to Columbia University or Cardiovascular Research Foundation for consulting or speaking engagements in which Dr Kirtane controlled the content. Dr Kirtane also reports consulting for IMDS; and travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Daemen receives institutional grant/research support from AstraZeneca, Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, Pie Medical, and ReCor Medical. Dr Pathak declares consulting honoraria from Medtronic, ReCor Medical, Ablative Solutions, and CVRx and educational and research grants from Medtronic, ReCor Medical, and Ablative Solutions. Dr Ukena reports consulting and lecture honoraria from Bayer, Boehringer Ingelheim, Medtronic, and Pfizer. Dr Lurz declares institutional grants from ReCor Medical. Dr Grassi declares lecture honoraria from Medtronic and Merck. Dr Finn receives research grants from ReCor Medical and Medtronic through CVPath, and honoraria from Medtronic. Dr Morice declares being the chief executive officer and shareholder of CERC. Dr J{\"u}ni serves as an unpaid steering committee member of trials funded by Abbott Vascular, AstraZeneca, Biotronik, Biosensors, St Jude Medical, Terumo, and The Medicines Company; receives institutional research grants from Appili Therapeutics, AstraZeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company; and receives institutional honoraria for participation in advisory boards or consulting from Amgen, Ava, and Fresenius, but has not received personal payments by any pharmaceutical company or device manufacturer. Dr Stone has received speaker or other honoraria from Terumo, Cook, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity/options from Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and the MedFocus family of funds. The other authors report no conflicts. Publisher Copyright: {\textcopyright} 2022 Lippincott Williams and Wilkins. All rights reserved.",
year = "2022",
month = mar,
day = "15",
doi = "10.1161/CIRCULATIONAHA.121.057687",
language = "English",
volume = "145",
pages = "847--863",
journal = "Circulation",
issn = "0009-7322",
publisher = "Lippincott Williams and Wilkins Ltd.",
number = "11",
}