1. 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.
- Author
-
Gordin D, Fadl Elmula FEM, Andersson B, Gottsäter A, Elf J, Kahan T, Christensen KL, Vikatmaa P, Vikatmaa L, Bastholm Olesen T, Groop PH, Olsen MH, and Tikkanen I
- Subjects
- Adolescent, Adult, Aged, Double-Blind Method, Heart physiopathology, Humans, Hypertension physiopathology, Middle Aged, Prostheses and Implants, Young Adult, Baroreflex, Blood Pressure, Electric Stimulation Therapy methods, Hypertension therapy
- 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.
- Published
- 2017
- Full Text
- View/download PDF