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High-Altitude Polycythemia Study

Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07600086
Acronym
NIV-HAPC
Enrollment
70
Registered
2026-05-20
Start date
2026-05-01
Completion date
2028-12-01
Last updated
2026-05-20

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

Conditions

HAPC, High-altitude Polycythemia

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.

Interventions

OTHERNon-invasive ventilator

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

Sponsors

Tibet Autonomous Region People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

1. Diagnosed with high-altitude polycythemia (HAPC). 2. Aged 18 years or older, with no gender restriction. 3. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

1. Disturbance of consciousness. 2. Inability to independently clear airway secretions, with the risk of aspiration. 3. Severe upper gastrointestinal bleeding. 4. Hemodynamic instability. 5. Upper airway obstruction. 6. Un drained pneumothorax or mediastinal emphysema. 7. Conditions that prevent mask wearing, such as facial trauma or deformity. 8. Patient non-compliance.

Design outcomes

Primary

MeasureTime frameDescription
Change in Hemoglobin (Hb) ConcentrationBaseline, 3 months, 6 months after treatment initiationThe 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.

Secondary

MeasureTime frameDescription
Change in Serum uric acid and blood lipid levelsBaseline, 6 monthsChanges in serum uric acid, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured.

Countries

China

Contacts

CONTACTGesang Luobu, MD
kelsangnorbu@hotmail.com8618108912487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026