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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)

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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

Tracking Information
First Submitted Date  ICMJE October 7, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date August 6, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Change in systolic ambulatory blood pressure in response to BAT therapy [ Time Frame: 8 months ]
Unit: mmHg
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Change in systolic ambulatory blood pressure in response to BAT therapy [ Time Frame: 16 months ]
Unit: mmHg
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Change in home blood pressure in response to BAT therapy [ Time Frame: 16 months ]
    Unit: mmHg
  • Change in office blood pressure in response to BAT therapy [ Time Frame: 16 months ]
    Unit: mmHg
  • Change in autonomic function in response to BAT therapy [ Time Frame: 16 months ]
    Unit: ms/mmHg
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Baroreflex Activation Therapy (BAT) on Blood Pressure and Sympathetic Function in Patients With Resistant Hypertension (The Nordic BAT Study)
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Resistant Hypertension
Intervention  ICMJE
  • Device: BAT
    Baroreflex activation therapy device ON
  • Other: Placebo
    Baroreflex activation therapy device OFF
Study Arms  ICMJE
  • Active Comparator: Baroreflex activation therapy
    BAT ON
    Intervention: Device: BAT
  • Placebo Comparator: Placebo
    BAT OFF
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2028
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Gordin, MD DMSc +35894711
Contact: Ilkka Tikkanen, Ass Prof +35894711
Listed Location Countries  ICMJE Denmark,   Finland,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02572024
Other Study ID Numbers  ICMJE BATstudy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Gordin, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE
  • Skane University Hospital
  • Sahlgrenska University Hospital, Sweden
  • Karolinska Institutet
  • Odense University Hospital
  • University of Oslo
  • University of Helsinki
Investigators  ICMJE Not Provided
PRS Account Helsinki University Central Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP