The Effect of Baroreflex Activation Therapy (BAT) on Blood Pressure and Sympathetic Function in Patients With Resistant Hypertension (The Nordic BAT Study) (The Nordic BAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02572024|
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : August 6, 2019
Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. However, the current treatment modalities have not been optimal in targeting the compensatory changes in sympathetic nervous system function and new strategies have been warranted.
Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT both long-term safety and efficacy in a large-scale, randomized, double blind, controlled trial has been shown. However, the trial design and BAT methodology resulted in that the first generation Rheos® system did not achieve the prespecified endpoints for short-term safety and efficacy.
Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been developed to address these limitations although randomized, double blind, controlled clinical trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension.
Based on these data the aim of this randomized, double-blind, parallel-design clinical trial is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as well as arterial and cardiac function and structure using non-invasive high technology methodology, in a Nordic multicentre study.
This study will include 100 patients with RH (20 from Helsinki). Eligible patients are between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric illness, severe cardiovascular disease, or any complication that is a risk to the planned surgery are exclusion criteria.
The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end points are to test whether BAT reduces home blood pressure during follow-up compared to continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured as eg. baroreflex sensitivity and heart rate variability.
|Condition or disease||Intervention/treatment||Phase|
|Resistant Hypertension||Device: BAT Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||April 2028|
Active Comparator: Baroreflex activation therapy
Baroreflex activation therapy device ON
Placebo Comparator: Placebo
Baroreflex activation therapy device OFF
- Change in systolic ambulatory blood pressure in response to BAT therapy [ Time Frame: 8 months ]Unit: mmHg
- Change in systolic ambulatory blood pressure in response to BAT therapy [ Time Frame: 19 months ]Unit: mmHg
- Change in home/office blood pressure in response to BAT therapy [ Time Frame: 19 months ]Unit: mmHg
- Change in autonomic function in response to BAT therapy [ Time Frame: 19 months ]Unit: ms/mmHg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572024
|Contact: Daniel Gordin, MD DMSc||+35894711|
|Contact: Ilkka Tikkanen, Ass Prof||+35894711|
|Odense University Hospital||Recruiting|
|Contact: Michael Hecht Olsen, Prof|
|Helsinki University Central Hospital||Recruiting|
|Contact: Daniel Gordin, MD DMSc +35894711|
|Contact: Ilkka Tikkanen, MD DMSc +35894711|
|University of Oslo||Not yet recruiting|
|Contact: Fadl Elmula, MD DMSc|
|Sahlgrenska University Hospital, Sweden||Not yet recruiting|
|Contact: Bert Andersson, MD DMScl|
|Skåne University Hospital||Not yet recruiting|
|Contact: Anders Gottsäter, MD DMSc|