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

Autor: Kandzari DE; Piedmont Heart Institute, Atlanta, GA (D.E.K.)., Mahfoud F; Piedmont Heart Institute, Atlanta, GA (D.E.K.).; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge (F.M.)., Weber MA; State University of New York, Downstate Medical College, New York (M.A.W.)., Townsend R; University of Pennsylvania, Perelman School of Medicine, Philadelphia (R.T.)., Parati G; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy (G.P.).; Istituto Auxologico Italiano Istituto di Ricovero e Cura a Carattere scientifico (IRCCS), Ospedale San Luca, Milan, Italy (G.P.)., Fisher NDL; Brigham and Women's Hospital, Boston, MA (N.D.L.F.)., Lobo MD; Barts National Institute for Health Research Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, United Kingdom (M.D.L.)., Bloch M; University of Nevada/Reno School of Medicine (M. Bloch).; Renown Institute for Heart and Vascular Health, Reno, NV (M. Bloch)., Böhm M; Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany (F.M., M. Böhm, C.U.)., Sharp ASP; University Hospital of Wales, Cardiff and University of Exeter, United Kingdom (A.S.P.S.)., Schmieder RE; Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University Erlangen/Nürnberg, Germany (R.E.S.)., Azizi M; University of Paris, Institut national de la santé et de la recherche médicale (INSERM), Centre d'investigation clinique 418, Assistance Publique-Hôpitaux de Paris Hypertension Department and Département médico-universitaire Cardiologie Rein Transplantation Neurovasculaire, Georges Pompidou European Hospital, France (M.A.)., Schlaich MP; Dobney Hypertension Centre, School of Medicine-Royal Perth Hospital Unit and Research Foundation, University of Western Australia (M.P.S.)., Papademetriou V; Department of Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.)., Kirtane AJ; Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York' NY (A.J.K.).; Cardiovascular Research Foundation, New York (A.J.K., R.M., G.W.S.)., Daemen J; Thoraxcenter, Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands (J.D., E.S.)., Pathak A; Department of Cardiovasculaire Medicine, European Society of Hypertension Excellence Center, Princess Grace Hospital, Monaco (A.P.).; Centre for Anthropobiology and Genomics of Toulouse, Toulouse, France (A.P.)., Ukena C; Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany (F.M., M. Böhm, C.U.)., Lurz P; Heart Center Leipzig at University of Leipzig, Germany (P.L.)., Grassi G; Clinica Medica University Milano-Bicocca, Milan, Italy (G.G.)., Myers M; Division of Cardiology, Sunnybrook Health Sciences Centre (M.M.), University of Toronto, Canada., Finn AV; CVPath Institute, Gaithersburg, MD (A.V.F.)., Morice MC; CERC, Paris, France (M.-C.M.)., Mehran R; Cardiovascular Research Foundation, New York (A.J.K., R.M., G.W.S.).; Mount Sinai Hospital, New York (R.M., G.W.S.)., Jüni P; Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation (P.J.), University of Toronto, Canada., Stone GW; Cardiovascular Research Foundation, New York (A.J.K., R.M., G.W.S.)., Krucoff MW; Duke Clinical Research Institute, Durham, NC (M.K.)., Whelton PK; Departments of Epidemiology and Medicine, Tulane University Health Sciences Center, New Orleans, LA (P.K.W.)., Tsioufis K; 1st Department of Cardiology, National and Kapodistrian University of Athens, Hippocratio Hospital, Greece (K.T.)., Cutlip DE; Baim Institute for Clinical Research, Boston, MA (D.E.C.).; Beth Israel Deaconess Medical Center, Boston, MA (D.E.C.)., Spitzer E; Cardialysis, Rotterdam, The Netherlands (J.D., E.S.).
Jazyk: angličtina
Zdroj: Circulation [Circulation] 2022 Mar 15; Vol. 145 (11), pp. 847-863. Date of Electronic Publication: 2022 Mar 14.
DOI: 10.1161/CIRCULATIONAHA.121.057687
Abstrakt: 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.
Databáze: MEDLINE