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*

Daniel Gordin; Fadl Elmula M. Fadl Elmula; Bert Andersson; Anders Gottsäter; Johan Elf; Thomas Kahan; Kent Lodberg Christensen; Pirkka Vikatmaa; Leena Vikatmaa; Thomas Bastholm Olesen; Per Henrik Groop; Michael Hecht Olsen; Ilkka Tikkanen; on behalf of the Nordic BAT Study Group

doi:10.1080/08037051.2017.1332477

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*

Daniel Gordin^*
, Fadl Elmula M. Fadl Elmula
, Bert Andersson
, Anders Gottsäter
, Johan Elf
, Thomas Kahan
, Kent Lodberg Christensen
, Pirkka Vikatmaa
, Leena Vikatmaa
, Thomas Bastholm Olesen
, Per Henrik Groop
, Michael Hecht Olsen
, Ilkka Tikkanen
, on behalf of the Nordic BAT Study Group

^*Corresponding author for this work

Medicine (HOL)

Research output: Contribution to journal › Article › Research › peer-review

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.

Original language	English
Pages (from-to)	294-302
Number of pages	9
Journal	Blood Pressure
Volume	26
Issue number	5
DOIs	https://doi.org/10.1080/08037051.2017.1332477
Publication status	Published - 3 Sept 2017

Funding

The Nordic BAT Study is endorsed by the Nordic Hypertension Societies in Denmark, Finland, Norway, and Sweden. Mira Korolainen, Anita Makela, Leena Mantyla, Anna Sandelin, Jaana Tuomikangas, and Maikki Parkkonen are acknowledged for excellent technical assistance. Sources of funding: Folkh€alsan Research Foundation, the Wilhelm and Else Stockmann Foundation, the Liv och H€alsa Foundation, the Finnish Medical Society (Finska L€akares€allskapet), the Finnish Medical Foundation, The Swedish Cultural Foundation in Finland, and the Dorothea Olivia, Karl Walter och Jarl Walter Perkléns Foundation. DG has received consulting fees/lecture honoraria from Fresenius Medical Care and GE Healthcare, and support for travel to meetings from Sanofi and CVRx. JE has received lecture honoraria from Boehringer Ingelheim, Pfizer, and Leo Pharma. TK has received Research Grants to Karolinska Institutet from Medtronics and Recor. PV has received consulting fees from GE Healthcare, and support for travel to meetings from AL Gore medical and CVRx. LV has received consulting fees from GE Healthcare, and support for travel to meetings from CVRx. TBO has received consulting fees/lecture honoraria from AstraZeneca. P-H Groop has served on advisory boards for AbbVie, AstraZeneca, Boehringer Ingelheim, Cebix, Eli Lilly, Janssen, Medscape, MSD, Novartis, Novo Nordisk and Sanofi. P-H Groop has received lecture honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genzyme, MSD, Novartis, Novo Nordisk, and Sanofi. P-H Groop has received investigator-initiated grants from Eli Lilly and Roche. MHO has received personal research grant from Novo Nordisk Foundation. I.T. has received consulting fees/ lecture honoraria from AstraZeneca, Boehringer Ingelheim, Merck Sharp and Dohme, Novartis, Orion Pharma and Servier and support for travel to meetings from Boehringer Ingelheim and CVRx. No other conflicts of interest were reported. Sources of funding: Folkh€alsan Research Foundation, the Wilhelm and Else Stockmann Foundation, the Liv och H€alsa Foundation, the Finnish Medical Society (Finska L€akares€allskapet), the Finnish Medical Foundation, The Swedish Cultural Foundation in Finland, and the Dorothea Olivia, Karl Walter och Jarl Walter Perkléns Foundation.

Keywords

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

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10.1080/08037051.2017.1332477

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Gordin, D., Fadl Elmula, F. E. M., Andersson, B., Gottsäter, A., Elf, J., Kahan, T., Christensen, K. L., Vikatmaa, P., Vikatmaa, L., Bastholm Olesen, T., Groop, P. H., Olsen, M. H., Tikkanen, I., & on behalf of the Nordic BAT Study Group (2017). 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*. Blood Pressure, 26(5), 294-302. https://doi.org/10.1080/08037051.2017.1332477

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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*",

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.",

keywords = "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",

author = "Daniel Gordin and \{Fadl Elmula\}, \{Fadl Elmula M.\} and Bert Andersson and Anders Gotts{\"a}ter and Johan Elf and Thomas Kahan and Christensen, \{Kent Lodberg\} and Pirkka Vikatmaa and Leena Vikatmaa and \{Bastholm Olesen\}, Thomas and Groop, \{Per Henrik\} and Olsen, \{Michael Hecht\} and Ilkka Tikkanen and \{on behalf of the Nordic BAT Study Group\}",

year = "2017",

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doi = "10.1080/08037051.2017.1332477",

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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, Tikkanen, I & on behalf of the Nordic BAT Study Group 2017, '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*', Blood Pressure, vol. 26, no. 5, pp. 294-302. https://doi.org/10.1080/08037051.2017.1332477

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 et al.
In: Blood Pressure, Vol. 26, No. 5, 03.09.2017, p. 294-302.

Research output: Contribution to journal › Article › Research › peer-review

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 - 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

AU - on behalf of the Nordic BAT Study Group

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 - https://www.scopus.com/pages/publications/85020674632

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 -

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*

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Keywords

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