Hypertension
Conditions
Brief summary
This study is a multicenter, prospective, randomized, open-label, parallel-controlled clinical trial. The study participants are adult patients with hypertension who have been long-term residents (for \>6 months) in high-altitude regions (≥2500 m). They are randomly assigned to one of two groups: a conventional medication group and a remote ischemic conditioning (RIC) intervention group. The study aims to evaluate the effectiveness of a standardized 30-day RIC intervention, as an add-on to conventional antihypertensive medication, for reducing blood pressure in hypertensive immigrants living at high altitude.
Interventions
DEVICERIC
Participants will undergo a 7-day remote ischemic conditioning (RIC) intervention prior to ascending to high altitude. On the day following the completion of the RIC intervention, they will ascend to a high-altitude region (\>2500 m). Standardized RIC treatment will be administered using a dedicated RIC device. Each intervention session consists of 5 cycles. Every cycle includes 5 minutes of bilateral upper limb ischemia followed by 5 minutes of reperfusion. The cuff pressure for inducing ischemia is set at 200 mmHg. The intervention is administered twice daily for 30 consecutive days.
Sponsors
Capital Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Age 18-60 years, of either sex; Continuous residence in a high-altitude region (\>2500 m) for more than 6 months, with no plan for long-term departure from the plateau during the study period; Meeting the diagnostic criteria for essential hypertension; Willing to provide written informed consent.
Exclusion criteria
Evidence of secondary hypertension; Severe dysfunction of vital organs (e.g., heart, liver, kidney, lungs); Active malignancy, uncontrolled hyperthyroidism, active autoimmune disease, or poorly controlled diabetes mellitus; Office blood pressure ≥180/110 mmHg, or 24-hour average blood pressure ≥170/100 mmHg; Hospitalization for hypertensive crisis or emergency at least once within the past 3 months; History of cardiovascular or cerebrovascular event within the past 3 months; Pregnancy, planned pregnancy, or lactation for female participants; Contraindications to RIC (e.g., severe peripheral arterial disease, venous thrombosis, or soft tissue injury in the upper limbs); Any other condition deemed by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in 24-hour mean systolic blood pressure from baseline. | 30 days |
Outcome results
None listed