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

• Published in: Blood pressure Vol. 26; no. 5; pp. 294 - 302
• Main Authors: Gordin, Daniel, Fadl Elmula, Fadl Elmula M, Andersson, Bert, Gottsäter, Anders, Elf, Johan, Kahan, Thomas, Christensen, Kent Lodberg, Vikatmaa, Pirkka, Vikatmaa, Leena, Bastholm Olesen, Thomas, Groop, Per-Henrik, Olsen, Michael Hecht, Tikkanen, Ilkka
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis Group 01-01-2017
• Subjects: Adolescent; Adult; Aged; ambulatory blood pressure measurement; Baroreflex; baroreflex activation therapy; baroreflex sensitivity; Blood Pressure; cardiac autonomic function; diabetes; Double-Blind Method; Electric Stimulation Therapy - methods; Heart - physiopathology; heart rate variability; Humans; Hypertension - physiopathology; Hypertension - therapy; Middle Aged; myocardial infarction; peripheral vascular disease; Prostheses and Implants; refractory hypertension; resistant hypertension; Young Adult; baroreflex sensitivity; refractory hypertension; heart rate variability; cardiac autonomic function; myocardial infarction; baroreflex activation therapy; diabetes; resistant hypertension; peripheral vascular disease; Ambulatory blood pressure measurement
• ISSN: 0803-7051; 1651-1999
• DOI: 10.1080/08037051.2017.1332477

To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension.
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).
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.
This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.