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Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus

David E Kandzari1, Felix Mahfoud1,2, Michael A Weber3

  • 1Piedmont Heart Institute, Atlanta, GA (D.E.K.).

Circulation
|March 14, 2022
PubMed

Insights

Device-based therapies offer new hypertension treatments. Standardizing clinical trial design and definitions is crucial for comparing results and advancing research on these innovative approaches.

Area of Science:

  • Cardiovascular Medicine
  • Hypertension Research
  • Medical Device Development

Background:

  • High prevalence of uncontrolled blood pressure and medication nonadherence necessitate novel hypertension treatments.
  • Device-based therapies are expanding, requiring standardized clinical trial methodologies.
  • Existing trial designs lack consistency, hindering comparability and data pooling.

Purpose of the Study:

  • To establish consensus principles for clinical trial design and outcome definitions for device-based hypertension therapies.
  • To address challenges in evaluating new technologies for hypertension treatment.
  • To promote consistency in research for the world's leading cause of death and disability.

Main Methods:

  • Integration of evolving evidence and expert consensus from the Hypertension Academic Research Consortium (HARC).
  • Inclusion of regulatory perspectives on clinical trial design and methodology.
  • Development of pragmatic consensus principles for study design and outcome definitions.

Main Results:

  • Proposed standardized methods for blood pressure assessment.
  • Recommendations for effectiveness measures beyond blood pressure alone.
  • Guidelines for defining safety outcomes in clinical studies.

Conclusions:

  • Standardization is paramount for trial comparability and data poolability in device-based hypertension research.
  • The HARC document provides a framework for evaluating emerging hypertension technologies.
  • Adoption of these principles will advance the development of effective treatments for hypertension.

Keywords:
clinical trialshypertensionoutcomesrenal denervation

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