Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium
David E. Kandzari, Felix Mahfoud, Michael A. Weber, Raymond Townsend, Gianfranco Parati, Naomi D.L. Fisher, Melvin D. Lobo, Michael Bloch, Michael Böhm, Andrew S.P. Sharp, Roland E. Schmieder, Michel Azizi, Markus P. Schlaich, Vasilios Papademetriou, Ajay J. Kirtane, Joost Daemen, Atul Pathak, Christian Ukena, Philipp Lurz, Guido Grassi, Martin Myers, Aloke V. Finn, Marie-Claude Morice, Roxana Mehran, Peter Jüni, Gregg W. Stone, Mitchell W. Krucoff, Paul K. Whelton, Konstantinos Tsioufis, Donald E. Cutlip, Ernest Spitzer
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.