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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07562464
Enrollment
222
Registered
2026-05-01
Start date
2026-05-20
Completion date
2028-06-30
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Polycythemia

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.

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 90 consecutive days.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Percentage change in hemoglobin and hematocrit from baseline.90 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026