Why the study?
Expanding device-based hypertension therapies underscore the need for consistency in clinical trial design, conduct, and outcome definitions to permit comparability and data poolability.
This consensus document provides standardized clinical trial design principles and outcome definitions for evaluating device-based therapies for hypertension.
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Standardizes future device hypertension trial designs; extends consensus frameworks to enable more comparable evidence generation.
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.
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A 2022 study conducted a review in Hypertension. Device-based therapies for hypertension was evaluated. The Hypertension Academic Research Consortium proposes pragmatic consensus clinical design principles and outcomes definitions for studies evaluating device-based hypertension therapies.
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