TerminatedNot Applicable

UK Registry for Baroreflex Activation Therapy

Stopped: Due to the pandemic

United Kingdom6 participantsStarted 2018-11-01

Plain-language summary

This study is a post-marketing open label single arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
✓. The study subjects will be either:
✓. For BPV group, evidence of peripheral baroreflex dysfunction as determined by non-invasive autonomic function testing
✓. Patients will have been established on a stable antihypertensive treatment regime for at least 1 month by the time of participation in the study and changes in pharmacological intervention for the duration of the trial are to be avoided unless clinically mandated.

What they're measuring

Ambulatory Systolic & Diastolic Blood Pressure changes in patients with uncontrolled (refractory) hypertension

Timeframe: 6 months

Ambulatory Systolic & Diastolic Blood Pressure variability change in patients with highly variable BP due to baroreflex failure

Timeframe: 6 months

Incidence of Treatment-Emergent Adverse Events in both groups of patients

Timeframe: 6 months

Trial details

NCT IDNCT03730519

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-01

View on ClinicalTrials.gov More Baroreflex Failure Syndrome trials