- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07562477
Efficacy of Remote Ischemic Conditioning for Hypertension in High-Altitude Immigrant Populations
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: RIC group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage change in 24-hour mean systolic blood pressure from baseline.
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIC-HIP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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