SCRATCH HTN
Research type
Research Study
Full title
Sham controlled Randomized Control Trial evaluating the Safety, Acceptability and Efficacy of Autonomic neuromodulation using trans-cutaneous vagal sensory stimulation in uncontrolled hypertensive patients: a pilot study evaluating a novel non-invasive device-based strategy.
IRAS ID
302061
Contact name
Ajay Gupta
Contact email
Sponsor organisation
Barts Health NHS Trust & Queen Mary University of London
ISRCTN Number
ISRCTN14509154
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
High blood pressure (BP) is the leading risk factor for death and illness from a cardiovascular event, and managing high BP is a key focus of treatment for cardiovascular diseases. Antihypertensive drugs (drugs that aim to lower BP) are widely available, however a high number of people with high BP fail to achieve a healthy BP value despite receiving 1 or more anti-hypertensive medications. For uncontrolled hypertensive patients, including drug-resistant patients, the lack of an effective therapy is a major health challenge and an urgent unmet clinical need.
One potentially highly effective strategy to improve BP control in hypertension is via redressing the nervous system imbalance, which is linked with the development of hypertension; the brain controls the cardiovascular system by sending commands through the nervous system.
In this study, we will utilise a device that produces a very small electrical current to the nerves at the front area of the ears (the tragus). With this strategy, we aim to redress the nervous system imbalance and treat hypertension.
We aim to enrol 63 hypertensive participants, who will be randomly be allocated to receive the active or the inactive device in a 2:1 ratio (neither the clinical study team nor the participants will know who will receive the active device and who will receive the inactive). The participants will be asked to use the device for 30 minutes, daily for the first 14 days of the study, and then, once weekly for 10 weeks. The aim of the study is to establish that the device is safe, easy to use and acceptable by the patient, and that it has the potential to lower blood pressure in hypertensive patients.REC name
West of Scotland REC 4
REC reference
21/WS/0157
Date of REC Opinion
10 Jan 2022
REC opinion
Further Information Favourable Opinion