Daniel Gordin1,2,3, Fadl Elmula M Fadl Elmula4, Bert Andersson5, Anders Gottsäter6, Johan Elf6, Thomas Kahan7, Kent Lodberg Christensen8, Pirkka Vikatmaa9, Leena Vikatmaa10, Thomas Bastholm Olesen11, Per-Henrik Groop1,2,3,12, Michael Hecht Olsen13, Ilkka Tikkanen1,2,14. 1. a Helsinki Hypertension Centre of Excellence , University of Helsinki, Helsinki University Hospital , Helsinki , Finland. 2. b Abdominal Center Nephrology , University of Helsinki, Helsinki University Hospital , Helsinki , Finland. 3. c Folkhälsan Institute of Genetics , Folkhälsan Research Center, Biomedicum Helsinki , Helsinki , Finland. 4. d Cardiovascular and Renal Research Centre, Department of Internal Medicine , Oslo University Hospital , Oslo , Norway. 5. e Department of Molecular and Clinical Medicine , Göteborgs Universitet, Sahlgrenska sjukhuset , Göteborg , Sweden. 6. f Department of Vascular Diseases, Malmö Hypertension Centre of Excellence , Lund University, Skåne University Hospital , Malmö, Sweden. 7. g Department of Clinical Sciences, Division of Cardiovascular Medicine , Danderyd Hospital, Karolinska Institutet , Stockholm , Sweden. 8. h Blood Pressure Clinic, Department of Cardiology , University Hospital of Aarhus , Aarhus , Denmark. 9. i Abdominal Center, Vascular Surgery , Helsinki University Hospital , Helsinki , Finland. 10. j Department of Anesthesiology, Intensive Care and Pain Medicine , University of Helsinki, Helsinki University Hospital , Helsinki , Finland. 11. k Cardiovascular and Metabolic Preventive Clinic, Department of Endocrinology , Odense University Hospital , Odense , Denmark. 12. l Baker IDI Heart and Diabetes Institute , Melbourne , VIC , Australia. 13. m Department of Internal Medicine , Holbaek Hospital, Centre for Individualized Medicine in Arterial Diseases (CIMA), Odense University Hospital , Odense , Denmark. 14. n Minerva Institute for Medical Research , Helsinki , Finland.
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.
RCT Entities:
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.
Authors: Jasenka Zubcevic; Elaine M Richards; Tao Yang; Seungbum Kim; Colin Sumners; Carl J Pepine; Mohan K Raizada Journal: Circ Res Date: 2019-06-20 Impact factor: 17.367
Authors: Karsten Heusser; Arvo Thöne; Axel Lipp; Jan Menne; Joachim Beige; Hannes Reuter; Fabian Hoffmann; Marcel Halbach; Siegfried Eckert; Manuel Wallbach; Michael Koziolek; Helge Haarmann; Michael J Joyner; Julian F R Paton; André Diedrich; Hermann Haller; Jens Jordan; Jens Tank Journal: Hypertension Date: 2019-12-02 Impact factor: 10.190