High Altitude Polycythemia
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Percentage change in hemoglobin and hematocrit from baseline. | 90 days |