High-Altitude Polycythemia Study

NCT07600086 | Not Yet Recruiting

• 1 other identifier: ME-TBHP-25-014
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the clinical efficacy of non-invasive ventilation (NIV) in treating patients with high-altitude polycythemia (HAPC). Participants will be enrolled according to the international diagnostic criteria for high-altitude polycythemia. The study will use both retrospective cohort and prospective study methods. All participants will receive standard basic care. In addition, the intervention group will receive non-invasive ventilation treatment using either BiPAP or CPAP mode. Key measurements, including routine blood tests, liver function, renal function, uric acid, blood lipid profile, electrocardiogram and echocardiography, will be collected as primary and secondary outcome measures to assess the effects of the treatment.

Conditions

High-altitude Polycythemia; HAPC

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin (Hb) Concentration

  The primary endpoint is the absolute change in blood hemoglobin concentration (g/dL) from baseline to 3-month and 6-month follow-up. A reduction in hemoglobin level is defined as a clinically significant improvement in high altitude polycythemia status.

  Baseline, 3 months, 6 months after treatment initiation

Secondary Outcomes (1)

• Change in Serum uric acid and blood lipid levels

  Baseline, 6 months

Study Arms (2)

Intervention Group (NIV Treatment)

EXPERIMENTAL

Patients receive standard basic care plus long-term non-invasive ventilation (NIV) therapy with CPAP or BiPAP mode. Treatment is administered daily, and efficacy is evaluated 3 to 6 months after the intervention.

Other: Non-invasive ventilator

Control Group (Standard Care Only)

NO INTERVENTION

Patients receive only standard basic care without non-invasive ventilation therapy. Efficacy is evaluated at the same time points (3 and 6 months) as the intervention group for comparison.

Interventions

Non-invasive ventilator OTHER

Treatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group.

Intervention Group (NIV Treatment)

Eligibility Criteria

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

You may qualify if:

• Diagnosed with high-altitude polycythemia (HAPC).
• Aged 18 years or older, with no gender restriction.
• Voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• Disturbance of consciousness.
• Inability to independently clear airway secretions, with the risk of aspiration.
• Severe upper gastrointestinal bleeding.
• Hemodynamic instability.
• Upper airway obstruction.
• Un drained pneumothorax or mediastinal emphysema.
• Conditions that prevent mask wearing, such as facial trauma or deformity.
• Patient non-compliance.

Sponsors & Collaborators

• Tibet Autonomous Region People's Hospital: lead

Study Sites (2)

People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 850000

Xizang, China

Location

Xizang Autonomous Region People's Hospital

Xizang, China

Location

Central Study Contacts

Gesang Luobu, MD

CONTACT

8618108912487; kelsangnorbu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Respiratory Medicine

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)