The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study*

The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study*

Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension. Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypert...

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Bibliographic Details
Main Authors: Daniel Gordin, Fadl Elmula M. Fadl Elmula, Bert Andersson, Anders Gottsäter, Johan Elf, Thomas Kahan, Kent Lodberg Christensen, Pirkka Vikatmaa, Leena Vikatmaa, Thomas Bastholm Olesen, Per-Henrik Groop, Michael Hecht Olsen, Ilkka Tikkanen
Format: Article
Language:English
Published: Taylor & Francis Group 2017-09-01
Series:Blood Pressure
Subjects:
ambulatory blood pressure measurement
baroreflex sensitivity
baroreflex activation therapy
cardiac autonomic function
diabetes
heart rate variability
myocardial infarction
peripheral vascular disease
refractory hypertension
resistant hypertension
Online Access:http://dx.doi.org/10.1080/08037051.2017.1332477
Description
Summary:Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension. Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of  ≥145 mm Hg, and/or a daytime diastolic ABPM of  ≥95 mm Hg after witnessed drug intake (including  ≥3 antihypertensive drugs, preferably including a diuretic). Results: The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety. Conclusions: This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.
ISSN:0803-7051
1651-1999

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