Remote Ischemic Conditioning for High Altitude Polycythemia in High-Altitude Immigrant Populations

NCT07562464 | Not Yet Recruiting Phase 3

• 1 other identifier: RIC-HAPIP
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, prospective, randomized, open-label, parallel-controlled clinical trial. The participants are adult patients with high-altitude polycythemia who have been long-term residents (for \>6 months) in regions at an altitude of ≥2500 meters. Participants 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 90-day RIC intervention, as an add-on to conventional medication, in managing high-altitude polycythemia.

Conditions

High Altitude Polycythemia

Outcome Measures

Primary Outcomes (1)

• Percentage change in hemoglobin and hematocrit from baseline.

  90 days

Study Arms (2)

RIC group

EXPERIMENTAL

Device: RIC

Control group

NO INTERVENTION

Interventions

RIC DEVICE

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 90 consecutive days.

RIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years, of either sex; Continuous residence in a high-altitude region (≥2500 meters) for more than 6 months, with no plan for long-term departure from the plateau during the study period; Meeting the diagnostic criteria for high-altitude polycythemia; Willing to provide written informed consent.

You may not qualify if:

• Other hematologic diseases, such as anemia or abnormal leukocytosis; Severe dysfunction of vital organs (e.g., heart, liver, kidney, lungs); Active malignancy, uncontrolled hyperthyroidism, active autoimmune disease, or poorly controlled diabetes mellitus; 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04