Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Skane University Hospital
Sahlgrenska University Hospital, Sweden
Karolinska Institutet
Odense University Hospital
University of Oslo
University of Helsinki
Information provided by (Responsible Party):
Daniel Gordin, Helsinki University Central Hospital

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Baroreflex activation therapy
BAT ON
Device: BAT
Baroreflex activation therapy device ON

Placebo Comparator: Placebo
BAT OFF
Other: Placebo
Baroreflex activation therapy device OFF




Primary Outcome Measures :
  1. Change in systolic ambulatory blood pressure in response to BAT therapy [ Time Frame: 8 months ]
    Unit: mmHg


Secondary Outcome Measures :
  1. Change in systolic ambulatory blood pressure in response to BAT therapy [ Time Frame: 19 months ]
    Unit: mmHg

  2. Change in home/office blood pressure in response to BAT therapy [ Time Frame: 19 months ]
    Unit: mmHg

  3. Change in autonomic function in response to BAT therapy [ Time Frame: 19 months ]
    Unit: ms/mmHg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients 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.

Exclusion Criteria:

  • Patients with secondary causes of hypertension will be excluded.
  • Further exclusion criteria are renal insufficiency with an estimated glomerular filtration rate ≤30 ml/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology [CKD-EPI] formula), untreated sleep apnoea, pregnancy, type 1 diabetes, alcohol or substance abuse or psychiatric illnesses, other heart rhythm than sinus (well controlled atrial fibrillation is not a contraindication), uncontrolled systolic heart failure (or an ejection fraction of less than 40% in echocardiography), aortic stenosis (mean gradient more than 25 mmHg in echocardiography).
  • Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months before enrolment will also be exclusion criteria.
  • Furthermore, known or suspected baroreflex failure or autonomic neuropathy, carotid artery stenosis as well as prior surgery, radiation, or endovascular stent placement in the carotid sinus region on both sides, as well as any complication that is a risk to the planned surgery are exclusion criteria.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Daniel Gordin, MD DMSc +35894711
Contact: Ilkka Tikkanen, Ass Prof +35894711

Locations
Layout table for location information
Denmark
Odense University Hospital Recruiting
Odense, Denmark
Contact: Michael Hecht Olsen, Prof         
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Daniel Gordin, MD DMSc    +35894711      
Contact: Ilkka Tikkanen, MD DMSc    +35894711      
Norway
University of Oslo Not yet recruiting
Oslo, Norway
Contact: Fadl Elmula, MD DMSc         
Sweden
Sahlgrenska University Hospital, Sweden Not yet recruiting
Göteborg, Sweden
Contact: Bert Andersson, MD DMScl         
Skåne University Hospital Not yet recruiting
Malmö, Sweden
Contact: Anders Gottsäter, MD DMSc         
Sponsors and Collaborators
Helsinki University Central Hospital
Skane University Hospital
Sahlgrenska University Hospital, Sweden
Karolinska Institutet
Odense University Hospital
University of Oslo
University of Helsinki
Layout table for additonal information
Responsible Party: Daniel Gordin, MD DMSc, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02572024    
Other Study ID Numbers: BATstudy
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases