Hypertension, Resistant to Conventional Therapy Clinical Trial
— UK-BATOfficial title:
Investigation of the Efficacy and Safety of Baroreflex Activation Therapy in Patients With Refractory Hypertension and Those With Highly Variable Blood Pressure Due to Peripheral Baroreflex Failure
Verified date | June 2023 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions. 2. The study subjects will be either: I. Refractory hypertensive patients (daytime systolic ambulatory BP (ABP) > 150 mmHg) in whom all pharmacological approaches to control BP have failed or were intolerable. or II. Symptomatic patients with exaggerated BPV documented on daytime ABP monitoring (SD >18 mmHg) who cannot achieve effective BP control with pharmacological approaches 3. For BPV group, evidence of peripheral baroreflex dysfunction as determined by non-invasive autonomic function testing 4. 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. Exclusion Criteria: - HTN secondary to an identifiable and treatable cause - Carotid atherosclerosis determined by ultrasound or angiographic evaluation greater than 50% stenosis - Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation - Bifurcation of the carotid on the side planned needs to be below level of mandible by ultrasound - Uncontrolled, symptomatic cardiac bradyarrhythmias. - Myocardial infarction, unstable angina or cerebral vascular accident within 3 months before implant. - Clinically significant cardiac valvular disease - Prior implant in the carotid sinus region, - Currently implanted electrical medical devices, - End stage renal (with eGFR <15 mL/min) or liver disease - Pregnancy or contemplating pregnancy. - BMI > 40 kg/sq m - Inability to tolerate ambulatory blood pressure monitoring - Patient with other co-morbidity likely to have life expectancy <3y - Systolic left heart failure with ejection fraction <40% |
Country | Name | City | State |
---|---|---|---|
United Kingdom | William Harvey Research Institute | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | CVRx, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in echocardiographic left ventricular mass in both groups of patients | 6 months | ||
Other | Change in pulse wave velocity in both groups of patients | 6 months | ||
Other | Change in antihypertensive whole medicine equivalent in both groups of patients | For each patient, the sum of the percentage of the maximum licensed dose (MLD) for each medicine gives the total whole medicine equivalent (WME). | 6 months | |
Primary | Ambulatory Systolic & Diastolic Blood Pressure changes in patients with uncontrolled (refractory) hypertension | 6 months | ||
Primary | Ambulatory Systolic & Diastolic Blood Pressure variability change in patients with highly variable BP due to baroreflex failure | 6 months | ||
Primary | Incidence of Treatment-Emergent Adverse Events in both groups of patients | 6 months | ||
Secondary | Change in European Quality of Life 5 dimension (Eq-5D) score in both groups of patients | Eq5D is a standardised/validated instrument to assess health outcome. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5D index of 1.0 indicates full health, and -0.59 denoted death | 6 months | |
Secondary | Changes in autonomic indices in both groups of patients | Non-invasive measurement of parasympathetic (vagal) tone and sympathetic tone using a Neuroscope measurement device with real time beat to beat BP measurement | 6 months |
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