Clinical Trials Logo
  1. Home
  2. High Blood Pressure
  3. NCT05179343

SCRATCH-HTN Study: Evaluating Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Hypertensive Patients — SCRATCH-HTN  

High Blood Pressure Clinical Trial

Official title:
Sham Controlled RCT Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Uncontrolled Hypertensive Patients: a Pilot Study

Clinical Trial Summary

This is a pilot, sham-controlled, double blind, single-site device clinical trial designed to evaluate the safety, acceptability and efficacy of non-invasive autonomic neuromodulation in a cohort of 63 adult patients with uncontrolled high blood pressure.

Clinical Trial Description

SCRATCH-HTN trial is a randomised sham-controlled study designed to evaluate the safety, acceptability, and efficacy of trans-cutaneous autonomic neurostimulation (tAN) in a cohort of uncontrolled medicated hypertensive patients. SCRATCH-HTN trial is designed to test the hypothesis that tAN treatment is safe and acceptable to the patient, improves the control of blood pressure in hypertension and sense of well-being amongst those who are receiving the active treatment as compared to those on sham treatment. The study will recruit 63 patients with systemic arterial hypertension (male and female aged ≥18 years) who are receiving between one and three oral antihypertensive medications and remain hypertensive with blood pressure (BP) above target levels detailed below in the eligibility criteria. The participants will be randomly allocated to the active (tAN) or sham (sham-tAN) arms of the trial on 2:1 basis, respectively. The total treatment duration is 12 weeks. Self-administration of 30 min of tAN or sham stimulations once per day for the first two weeks, and then once every week for the rest of the trial period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05179343
Study type Interventional
Source Queen Mary University of London
Contact Ajay K Gupta
Phone 020 7882 2858
Email ajay.gupta@qmul.ac.uk
Status Recruiting
Phase N/A
Start date August 1, 2022
Completion date December 31, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT03812614 - Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support N/A
Completed NCT03650166 - High BP and Home Monitoring Experience (HoME) Study N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Completed NCT01622400 - Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk N/A
Completed NCT00659672 - Effect of Whey Protein on Blood Pressure N/A
Completed NCT00473681 - Intervention Study to Control High Blood Pressure for Korean American N/A
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Active, not recruiting NCT05526092 - OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals N/A
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Recruiting NCT03753204 - Salt-Sensitivity and Immunity Cell Activation Phase 1/Phase 2
Not yet recruiting NCT04064281 - The Healthy Cantonese Diet on Cardiometabolic Syndrome N/A
Completed NCT04479384 - The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study. N/A
Completed NCT04082819 - MediBeat - HeartBeat Observation Trial N/A
Completed NCT03555344 - Effect of Mantra on Hypertensive Patients N/A
Withdrawn NCT03319823 - Treating Nocturnal Hypertension and Nocturia in African American Men Phase 4
Completed NCT00689819 - Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients N/A
Completed NCT00417170 - Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome Phase 2
Completed NCT00130156 - Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension Phase 4
Completed NCT05808556 - Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure N/A
Recruiting NCT05321368 - A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities N/A