A study evaluating the blood pressure lowering efficacy and safety of a novel self-administered device-based treatment (by stimulating nerves that control blood pressure) in participants with hypertension.
Trial primary objective: To determine whether treatment with tAN (transcutaneous autonomic neuromodulation) therapy can reduce daytime SBP in uncontrolled hypertensive subjects to a greater extent than treatment with a placebo sham therapy.Disease area: Hypertension – those with uncontrolled blood pressures despite being on medications
Details available hereStatus: In set-up, recruitment commencing in April 2022 Chief Investigator: Dr Ajay GuptaSponsor: Queen Mary University of LondonFunder: NIHR
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.
High 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 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. Participants will self-administer the device.
The aim of the study is to assess how effective the device is in the treatment of hypertension and whether it is comfortable and safe to use.
This study is conducted in accordance with the ethical standards of the institutional research ethics committee (REC number: 21/WS/0157) and is a registered clinical trial on clinicaltrials.gov (NCT05179343) and https://www.isrctn.com/ISRCTN14509154.
63 will be enrolled over a period of 18 months at the William Harvey Clinical Research Centre; part of Barts Health NHS Trust.
For further information about the study, please visit: SCRATCH-HTN or contact a member of the research team at firstname.lastname@example.org or Chief Investigator Dr Ajay Gupta at email@example.com