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. © 2022 Lippincott Williams and Wilkins. All rights reserved.
Authors:
Kandzari, D.E.
Mahfoud, F.
Weber, M.A.
Townsend, R.
Parati, G.
Fisher, N.D.L.
Lobo, M.D.
Bloch, M.
Böhm, M.
Sharp, A.S.P.
Schmieder, R.E.
Azizi, M.
Schlaich, M.P.
Papademetriou, V.
Kirtane, A.J.
Daemen, J.
Pathak, A.
Ukena, C.
Lurz, P.
Grassi, G.
Myers, M.
Finn, A.V.
Morice, M.-C.
Mehran, R.
Jüni, P.
Stone, G.W.
Krucoff, M.W.
Whelton, P.K.
Tsioufis, K.
Cutlip, D.E.
Spitzer, E.
Keywords:
antihypertensive agent, algorithm; augmentation index; blood pressure monitoring; blood pressure variability; cardiovascular risk; chronic kidney failure; clinical outcome; clinical trial (topic); consensus; device therapy; diastolic blood pressure; disease burden; disease severity; estimated glomerular filtration rate; European Quality of Life 5 Dimensions 3 Level questionnaire; follow up; heart left ventricle hypertrophy; heart rate; heart volume; Holter monitoring; human; hypertension; kidney denervation; medication compliance; neuromodulation; outcome assessment; patient safety; patient-reported outcome; pulse wave velocity; Review; systolic blood pressure; treatment response; consensus; hypertension, Clinical Trials as Topic; Consensus; Humans; Hypertension
