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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
(Trans-cutaneous Autonomic Neurostimulation) tAN treatment will be administered using AffeX-CT device (a device based on a totally TENS unit). AffeX device comprises of a battery-operated control unit, two electrode pairs arranged on ear clips and connected to the control unit with electrical leads. The AffeX device generates an electrical signal that is used to stimulate the nerves that naturally control the output from the sympathetic nervous system.
Sham Totally TENS device. The device is identical to the active device used in the study, but its only purpose is to act as a placebo. The ear-clip electrodes have been modified so that the electric current is not transmitted to the participant.
Barts Health NHS Trust
London, United Kingdom
Change in average daytime ambulatory Systolic Blood Pressure (SBP) from baseline to the end of treatment.
Daytime SBP values will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Change in average daytime ambulatory SBP and Diastolic Blood Pressure (DBP) from baseline and 1 month.
Daytime ambulatory SBP values will be obtained with 24hr ABPM
Time frame: from baseline to 1 month
Change in average daytime ambulatory DBP from baseline to the end of treatment.
Daytime ambulatory DBP values will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Controlled BP at the end of treatment defined as mean daytime ambulatory SBP<135 mmHg and mean daytime ambulatory DBP<85 mmHg.
Daytime ambulatory SBP and DBP will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Change in average 24-hour ambulatory SBP and DBP from baseline to the end of treatment.
Daytime ambulatory SBP and DBP will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Change in average office SBP and DBP from baseline to 1 month, and from baseline to the end of treatment (3 months).
Daytime ambulatory SBP and DBP will be obtained with a vital signs monitor
Time frame: baseline to 1 month and baseline to 3 months
Change in average daytime ambulatory HR, and in average night-time ambulatory HR from baseline to the end of treatment.
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Daytime and nigh-time ambulatory HR will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Change in BP variability defined as the coefficient of variation (SD/mean) of 24-hour ambulatory SBP, and of within-visit office SBP from baseline to the end of treatment.
24hr ambulatory SBP will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Change in Heart Rate (HR) variability defined as the coefficient of variation (SD/mean) of 24-hour ambulatory HR, and of within-visit office HR from baseline to the end of treatment.
24hr ambulatory HR will be obtained with 24hr ABPM
Time frame: from baseline to 3 months
Occurrence of a serious adverse event (SAE), fatal or non-fatal, within 3 months.
SAEs will be collected through patient interviews, reporting and monitoring
Time frame: from baseline to 3 months
The occurrence of a major cardiovascular event (MACE), including myocardial infarction (MI), stroke, and cardiovascular-related mortality within 3 months.
MACE will be collected through patient interviews, reporting and monitoring
Time frame: from baseline to 3 months
Change in Quality of life between baseline and the end of the treatment (3 months) using the EuroQol Visual Analogue score (0-100), and the EuroQol 5 Dimension (EQ5D) quality of life (QoL) questions.
EQ-5D-5L questionnaire
Time frame: from baseline to 3 months
Change in sleep quality between baseline and the end of the treatment using the Insomnia Severity Index (ISI), a 7-item questionnaire with each question allowing responses on a 5-point Likert scale from 0-4. Responses summed to give an overall score of 0
ISI questionnaires
Time frame: from baseline to 3 months
Adherence to trial therapy, assessed as the proportion of days out of total days in follow-up when therapy was self-administered, and the average daily duration of self-administered therapy over the 3 months of follow-up (90 days).
Study log-book
Time frame: from baseline to 3 months