The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)

NCT02572024 | Completed

• 1 other identifier: BATstudy
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 5

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.

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in systolic ambulatory blood pressure in response to BAT therapy

  Unit: mmHg

  8 months

Secondary Outcomes (3)

• Change in systolic ambulatory blood pressure in response to BAT therapy

  19 months

• Change in home/office blood pressure in response to BAT therapy

  19 months

• Change in autonomic function in response to BAT therapy

  19 months

Study Arms (2)

Baroreflex activation therapy

ACTIVE COMPARATOR

BAT ON

Device: BAT

Placebo

PLACEBO COMPARATOR

BAT OFF

Other: Placebo

Interventions

BAT DEVICE

Baroreflex activation therapy device ON

Baroreflex activation therapy

Placebo OTHER

Baroreflex activation therapy device OFF

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with secondary causes of hypertension will be excluded.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Odense University Hospital: collaborator
• University of Oslo: collaborator
• University of Helsinki: collaborator
• Sahlgrenska University Hospital: collaborator
• Skane University Hospital: collaborator

Study Sites (5)

Odense University Hospital

Odense, Denmark

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

University of Oslo

Oslo, Norway

Location

Sahlgrenska University Hospital, Sweden

Gothenburg, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD DMSc

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 8, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2022-03

Locations

NO (1); SE (2); FI (1); DK (1)