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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*

Gordin, Daniel; Fadl Elmula, Fadl Elmula M.; Andersson, Bert; Gottsäter, Anders LU ; Elf, Johan LU ; Kahan, Thomas; Christensen, Kent Lodberg; Vikatmaa, Pirkka; Vikatmaa, Leena and Bastholm Olesen, Thomas, et al. (2017) In Blood Pressure 26(5). p.294-302
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... (More)

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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@article{15d7dbed-088e-4f82-9f46-f27f8d173034,
  abstract     = {<p>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.</p>},
  author       = {Gordin, Daniel and Fadl Elmula, Fadl Elmula M. and Andersson, Bert and Gottsäter, Anders and Elf, Johan and Kahan, Thomas and Christensen, Kent Lodberg and Vikatmaa, Pirkka and Vikatmaa, Leena and Bastholm Olesen, Thomas and Groop, Per-Henrik and Olsen, Michael Hecht and Tikkanen, Ilkka and , },
  issn         = {0803-7051},
  keyword      = {Ambulatory blood pressure measurement,baroreflex activation therapy,baroreflex sensitivity,cardiac autonomic function,diabetes,heart rate variability,myocardial infarction,peripheral vascular disease,refractory hypertension,resistant hypertension},
  language     = {eng},
  month        = {06},
  number       = {5},
  pages        = {294--302},
  publisher    = {Taylor & Francis},
  series       = {Blood Pressure},
  title        = {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*},
  url          = {http://dx.doi.org/10.1080/08037051.2017.1332477},
  volume       = {26},
  year         = {2017},
}