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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High Altitude Polycythemia
• Intervention / Treatment: Device: RIC

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: RIC group	Device: RIC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in hemoglobin and hematocrit from baseline.	90 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RIC-HAPIP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No