Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium

Kandzari DE, Mahfoud F, Weber MA, Townsend R, Parati G, Fisher NDL, Lobo MD, Bloch M, Bohm M, Sharp ASP, Schmieder R, Azizi M, Schlaich MP, Papademetriou V, Kirtane AJ, Daemen J, Pathak A, Ukena C, Lurz P, Grassi G, Myers M, Finn A, Morice MC, Mehran R, Juni P, Stone GW, Krucoff MW, Whelton PK, Tsioufis K, Cutlip DE, Spitzer E (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Book Volume: 145

Pages Range: 847-863

Journal Issue: 11

DOI: 10.1161/CIRCULATIONAHA.121.057687

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.

Authors with CRIS profile

Involved external institutions

State University of New York at Albany (UNY Albany / UAlbany) United States (USA) (US) University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB Italy (IT) Brigham and Women's Hospital (BWH) United States (USA) (US) Queen Mary, University of London United Kingdom (GB) University of Nevada Las Vegas United States (USA) (US) Cardiff and Vale University Health Board United Kingdom (GB) University of Paris 4 - Paris-Sorbonne / Université paris IV Paris-Sorbonne France (FR) University of Western Australia (UWA) Australia (AU) Piedmont Healthcare United States (USA) (US) University of Pennsylvania United States (USA) (US) Universität des Saarlandes (UdS) Germany (DE) Universität Leipzig Germany (DE) University of Toronto Canada (CA) CVPath Institute United States (USA) (US) CERC Cardiovascular European Research Center France (FR) Cardiovascular Research Foundation United States (USA) (US) Duke University Medical Center United States (USA) (US) Tulane University United States (USA) (US) National and Kapodistrian University of Athens Greece (GR) Beth Israel Deaconess Medical Center (BIDMC) United States (USA) (US) Cardialysis Netherlands (NL) Veterans Health Administration (VHA) United States (USA) (US) Columbia University United States (USA) (US) Centre Hospitalier Princesse Grace Monaco (MC)

How to cite

APA:

Kandzari, D.E., Mahfoud, F., Weber, M.A., Townsend, R., Parati, G., Fisher, N.D.L.,... Spitzer, E. (2022). Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium. Circulation, 145(11), 847-863. https://doi.org/10.1161/CIRCULATIONAHA.121.057687

MLA:

Kandzari, David E., et al. "Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium." Circulation 145.11 (2022): 847-863.

BibTeX: Download