TY - JOUR
T1 - The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension
T2 - the rationale and design of the Nordic BAT study*
AU - on behalf of the Nordic BAT Study Group
AU - Gordin, Daniel
AU - Fadl Elmula, Fadl Elmula M.
AU - Andersson, Bert
AU - Gottsäter, Anders
AU - Elf, Johan
AU - Kahan, Thomas
AU - Christensen, Kent Lodberg
AU - Vikatmaa, Pirkka
AU - Vikatmaa, Leena
AU - Bastholm Olesen, Thomas
AU - Groop, Per Henrik
AU - Olsen, Michael Hecht
AU - Tikkanen, Ilkka
PY - 2017/9/3
Y1 - 2017/9/3
N2 - 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.
AB - 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.
KW - Ambulatory blood pressure measurement
KW - baroreflex activation therapy
KW - baroreflex sensitivity
KW - cardiac autonomic function
KW - diabetes
KW - heart rate variability
KW - myocardial infarction
KW - peripheral vascular disease
KW - refractory hypertension
KW - resistant hypertension
UR - http://www.scopus.com/inward/record.url?scp=85020674632&partnerID=8YFLogxK
U2 - 10.1080/08037051.2017.1332477
DO - 10.1080/08037051.2017.1332477
M3 - Article
C2 - 28595464
AN - SCOPUS:85020674632
SN - 0803-7051
VL - 26
SP - 294
EP - 302
JO - Blood Pressure
JF - Blood Pressure
IS - 5
ER -