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*

on behalf of the Nordic BAT Study Group, 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

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstract

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.

OriginalsprogEngelsk
Sider (fra-til)294-302
Antal sider9
TidsskriftBlood Pressure
Vol/bind26
Udgave nummer5
DOI
StatusUdgivet - 3 sep. 2017

Fingeraftryk

Udforsk hvilke forskningsemner '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*' indeholder.

Citationsformater