This phase clinical trial will investigate the effect of remote ischemic conditioning (RIC) in patients with borderline hypertension. The main outcome will be the change in blood pressure (BP) over 33 days.
The details
Hypertension or high blood pressure (BP) is a serious condition. Hypertension increases the risk of major events like a heart attack or stroke. Managing BP levels is important. BP is measured as systolic BP (SBP) and diastolic BP (DBP). Normal BP is 120/80 mm Hg. Increases in SBP/DBP are associated with an increased risk of stroke and heart attack. Increased SBP and normal DBP is called systolic hypertension (SHT). SHT is also associated with a higher risk of stroke.
Remote ischemic conditioning (RIC) is an experimental treatment. It works by temporarily restricting blood flow to an arm. This tricks the body into producing a protective response. This type of response can have protective effects on the heart. It is unclear if RIC can lower BP.
This study will investigate the effect of RIC in patients with borderline hypertension. The main outcome will be the change in BP over 33 days.
Who are they looking for?
This trial will recruit 180 patients with hypertension. Patients must have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) measurements ranging from 120-145 mmHg/75-90 mmHg. Patients cannot be taking BP-lowering medication.
Patients that have previously been treated previously with BP-lowering medications are excluded from the study. Patients with uncontrolled diabetes and heart rhythm disorders will also be excluded from the trial. Patients must not have other unstable medical conditions and must not be participating in another clinical trial.
How will it work
There will be 2 groups in this study. Patients will be randomly assigned to receive RIC or dummy RIC. During RIC, a cuff will be placed on an arm and inflated to 200 mmHg for 5 mins. The cuff will be then deflated for 5 minutes. This will be repeated 5 times twice a day. Patients in the dummy RIC group will have the same procedure but with the cuff inflated to 60 mmHg. Treatment will last up to 32 days.
The main outcome will be the change in BP at day 33. Inflammatory markers in the blood will also be tested before and after treatment.
