Using inhaled nitric oxide to treat high altitude pulmonary edema

A Single-center Prospective Randomized Controlled Trial of Inhaled Nitric Oxide in the Treatment of High Amplitude Pulmonary Edema(HAPE)

This study is testing if inhaled nitric oxide can help people with mild to moderate high altitude pulmonary edema feel better and improve their breathing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Novlead Inc. (Industry-sponsored)
• Locations: 1 site (Lhasa, Tibet)
• Trial ID: NCT06852924 on ClinicalTrials.gov

What this trial studies

This investigation evaluates the effectiveness of inhaled nitric oxide (iNO) in managing mild to moderate high altitude pulmonary edema (HAPE). The study employs a novel nitric oxide therapeutic device that generates and delivers nitric oxide gas in real-time, ensuring precise administration and monitoring of gas concentrations. Participants will be assessed on various parameters, including changes in oxygenation, symptom resolution, and imaging indicators over a treatment period of 3 to 7 days. The study aims to compare outcomes between those receiving iNO and a control group.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 65 with mild to moderate HAPE, as indicated by specific scoring and imaging criteria.

Not a fit: Patients with severe heart conditions or contraindications to nitric oxide therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery times and outcomes for patients suffering from high altitude pulmonary edema.

How similar studies have performed: While the use of inhaled nitric oxide has been explored in other contexts, this specific application for HAPE is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Individuals aged between 18 and 65 years.
2. A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018.
3. Chest X-ray findings that demonstrate either thickening of the lung texture bilaterally or the presence of nodular opacities in the lower regions of both lungs.
4. Capacity to provide informed consent in accordance with local regulatory requirements.

Exclusion Criteria:

1. Confirmed contraindications for the use of nitric oxide include the following (refer to "5.3.4 NO Contraindications"):

   * Severe hypoplasia of the left heart or duct-dependent congenital heart disease;
   * Life-threatening congenital anomalies and congestive heart failure;
   * Congenital methemoglobinemia;
   * Severe hemorrhagic conditions, including intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage.
2. Severe left ventricular dysfunction, characterized by a left ventricular ejection fraction (LVEF) of less than 40%.
3. Pulmonary edema resulting from other cardiac, pulmonary, thoracic, or systemic disorders.
4. Coexistence with high altitude cerebral edema.
5. A history of lung malignancy, lung resection, or lung transplantation.
6. Barotrauma, which may include pneumothorax, subcutaneous and mediastinal emphysema, or the presence of a closed drainage tube in the thoracic cavity.
7. Clinically significant or persistent thrombocytopenia, defined as a platelet count of less than 50×10\^9/L.
8. Administration of pulmonary hypertension medications, such as sildenafil, bosentan, or prostacyclins, within the preceding 30 days.
9. Noncompliance with study protocols and unwillingness to provide informed consent.
10. Any other conditions that the clinician deems render the subject unsuitable for participation in the study.

Where this trial is running

Lhasa, Tibet

• Tibet Fokang Hospital — Lhasa, Tibet, China (Recruiting)

Study contacts

• Principal investigator: Jingxin Cao — Tibet Fokind Hospital
• Study coordinator: Zhou Fang

Conditions High Altitude Pulmonary Hypertension; iNO; HAPE