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New treatment option for High Altitude Pulmonary Hypertension
Official title Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)
ClinicalTrials.gov ID: NCT06852924
What this study is testing
- What it's testing
- High Altitude Pulmonary Edema (HAPE) is a critical, non-cardiogenic pulmonary edema that manifests in high-altitude conditions, marked by the rapid onset of symptoms such as dyspnea, cough, frothy sputum, and cyanosis. It represents a significant cause of mortality among high-altitude illnesses due to its swift progression and elevated fatality rates if not addressed promptly.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Individuals aged between 18 and 65 years.
- A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018.
- Chest X-ray findings that demonstrate either thickening of the lung texture bilaterally or the presence of nodular opacities in the lower regions of...
- Capacity to provide informed consent in accordance with local regulatory requirements.
You likely can't join if
- 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.
- Severe left ventricular dysfunction, characterized by a left ventricular ejection fraction (LVEF) of less than 40%.
See the full eligibility criteria
- Individuals aged between 18 and 65 years.
- A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018.
- 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.
- Capacity to provide informed consent in accordance with local regulatory requirements.
- 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.
- Severe left ventricular dysfunction, characterized by a left ventricular ejection fraction (LVEF) of less than 40%.
- Pulmonary edema resulting from other cardiac, pulmonary, thoracic, or systemic disorders.
- Coexistence with high altitude cerebral edema.
- A history of lung malignancy, lung resection, or lung transplantation.
- Barotrauma, which may include pneumothorax, subcutaneous and mediastinal emphysema, or the presence of a closed drainage tube in the thoracic cavity.
- Clinically significant or persistent thrombocytopenia, defined as a platelet count of less than 50×10\^9/L.
- Administration of pulmonary hypertension medications, such as sildenafil, bosentan, or prostacyclins, within the preceding 30 days.
- Noncompliance with study protocols and unwillingness to provide informed consent.
- Any other conditions that the clinician deems render the subject unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Lhasa, Tibet, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lhasa, Tibet, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.