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*
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 hypert...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-09-01
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| Series: | Blood Pressure |
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| Online Access: | http://dx.doi.org/10.1080/08037051.2017.1332477 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Daniel Gordin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T00:40:19Z |
| format | Article |
| id | doaj.art-6f0052169034416ca6733f4f3677aab7 |
| institution | Directory Open Access Journal |
| issn | 0803-7051 1651-1999 |
| language | English |
| last_indexed | 2024-03-12T00:40:19Z |
| publishDate | 2017-09-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Blood Pressure |
| spelling | doaj.art-6f0052169034416ca6733f4f3677aab72023-09-15T08:45:21ZengTaylor & Francis GroupBlood Pressure0803-70511651-19992017-09-0126529430210.1080/08037051.2017.13324771332477The 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 Gordin0Fadl Elmula M. Fadl Elmula1Bert Andersson2Anders Gottsäter3Johan Elf4Thomas Kahan5Kent Lodberg Christensen6Pirkka Vikatmaa7Leena Vikatmaa8Thomas Bastholm Olesen9Per-Henrik Groop10Michael Hecht Olsen11Ilkka Tikkanen12University of Helsinki, Helsinki University HospitalOslo University HospitalGöteborgs Universitet, Sahlgrenska sjukhusetLund University, Skåne University HospitalLund University, Skåne University HospitalDanderyd Hospital, Karolinska InstitutetUniversity Hospital of AarhusHelsinki University HospitalUniversity of Helsinki, Helsinki University HospitalOdense University HospitalUniversity of Helsinki, Helsinki University HospitalHolbaek Hospital, Centre for Individualized Medicine in Arterial Diseases (CIMA), Odense University HospitalUniversity of Helsinki, Helsinki University HospitalObjective: 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.http://dx.doi.org/10.1080/08037051.2017.1332477ambulatory blood pressure measurementbaroreflex sensitivitybaroreflex activation therapycardiac autonomic functiondiabetesheart rate variabilitymyocardial infarctionperipheral vascular diseaserefractory hypertensionresistant hypertension |
| spellingShingle | 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 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 ambulatory blood pressure measurement baroreflex sensitivity baroreflex activation therapy cardiac autonomic function diabetes heart rate variability myocardial infarction peripheral vascular disease refractory hypertension resistant hypertension |
| 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* |
| title_full | 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* |
| title_fullStr | 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* |
| title_full_unstemmed | 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* |
| title_short | 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* |
| title_sort | 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 |
| topic | ambulatory blood pressure measurement baroreflex sensitivity baroreflex activation therapy cardiac autonomic function diabetes heart rate variability myocardial infarction peripheral vascular disease refractory hypertension resistant hypertension |
| url | http://dx.doi.org/10.1080/08037051.2017.1332477 |
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