The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)
Condition: Resistant Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    


Intervention name(s): BAT; Placebo
Intervention type(s): Device; Other
Intervention description(s): Baroreflex activation therapy device ON; Baroreflex activation therapy device OFF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment