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J Am Soc Hypertens. 2015 May;9(5):341-50. doi: 10.1016/j.jash.2015.02.012.

Renal denervation therapy for hypertension: pathways for moving development forward.

Author information

1
Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA. Electronic address: wwhite@uchc.edu.
2
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
3
University of Missouri, Columbia, MO, USA.
4
Piedmont Heart Institute, Atlanta, GA, USA.
5
Cedars-Sinai Medical Center, Los Angeles, CA, USA.
6
Virginia Commonwealth University Medical Center, Richmond, VA, USA.
7
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
8
Clinical Communications, Quintiles, Durham, NC, USA.
9
CVPath Institute, Gaithersburg, MD, USA.
10
Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA, USA.

Abstract

This scientific statement provides a summary of presentations and discussions at a cardiovascular Think Tank co-sponsored by the American Society of Hypertension (ASH), the United States Food and Drug Administration (FDA), and the National Heart, Lung, and Blood Institute (NHLBI) held in North Bethesda, Maryland, on June 26, 2014. Studies of device therapies for the treatment of hypertension are requested by regulators to evaluate their safety and efficacy during their development programs. Think Tank participants thought that important considerations in undertaking such studies were: (1) Preclinical assessment: how likely it is that both efficacy and safety data indicating benefit in humans will be obtained, and/or whether a plausible mechanism of action for efficacy can be identified; (2) Early human trial(s): the ability to determine that the device has an acceptable benefit-to-risk balance for its use in the intended patient population and without the influence of drug therapy during a short-term follow-up period; and (3) Pivotal Phase III trial(s): the ability to prove the effectiveness of the device in a broad population in which the trial can be made as non-confounded as possible while still allowing for the determination for benefits when added to antihypertensive therapies.

KEYWORDS:

American Society of Hypertension; clinical trials; device therapy for hypertension; renal denervation

PMID:
25979410
DOI:
10.1016/j.jash.2015.02.012
[Indexed for MEDLINE]
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