Key result
The Nordic BAT study is a randomized trial designed to evaluate whether baroreflex activation therapy reduces 24-hour systolic ambulatory blood pressure at 8 months in refractory hypertension.
Why the study?
Does baroreflex activation therapy reduce 24-hour systolic ambulatory blood pressure in patients with refractory hypertension?
RCT (n=100)
Double-blind
1:1 parallel-design
Yes
Does baroreflex activation therapy reduce 24-hour systolic ambulatory blood pressure in patients with refractory hypertension?
The Nordic BAT study is designed to evaluate whether baroreflex activation therapy reduces 24-hour systolic ambulatory blood pressure in patients with refractory hypertension.
First RCT testing baroreflex activation therapy on 24-hour SBP in refractory hypertension; will clarify its role or leave the question open.
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.
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Gordin et al. (2017) conducted an RCT in Refractory hypertension (n=100). Baroreflex activation therapy (BAT) vs. Continuous pharmacotherapy (BAT off) was evaluated on Reduction in 24-hour systolic ABPM at 8 months. The Nordic BAT study is a randomized trial designed to evaluate whether baroreflex activation therapy reduces 24-hour systolic ambulatory blood pressure at 8 months in refractory hypertension.
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