Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)

NCT06852924 | Recruiting DMC

• 1 other identifier: HAPE23-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. The pathophysiological mechanisms underlying HAPE include excessive hypoxic pulmonary vasoconstriction, increased permeability of the pulmonary vasculature, impaired clearance of fluid from the lungs, and systemic fluid retention. A pivotal factor in HAPE is pulmonary arterial hypertension (PAH), characterized by a progressive rise in pulmonary arterial pressure and resistance, which can ultimately lead to right heart failure. Recent developments in the management of HAPE have introduced inhaled nitric oxide (iNO) as a selective pulmonary vasodilator, which effectively lowers pulmonary arterial pressure and enhances oxygenation without inducing systemic hypotension. The INOwill N300 device, created by Nanjing Novlead Biotech, is a portable iNO delivery system that produces nitric oxide gas on-site, thereby obviating the need for gas cylinders. This device also facilitates real-time monitoring of nitric oxide, nitrogen dioxide, and oxygen concentrations, ensuring safe and effective treatment. This innovative strategy shows potential for improving clinical outcomes in patients with HAPE while addressing logistical challenges encountered in high-altitude environments.

Conditions

High Altitude Pulmonary Hypertension

Keywords

iNO; HAPE

Outcome Measures

Primary Outcomes (1)

• Change of Oxygen Index

  The change of oxygenation index (PaO2 or SpO2/FiO2) from baseline, and the time required for oxygenation index to improve by ≥20%

  Through study completion, an average of 5 days

Secondary Outcomes (3)

• Progression of HAPE

  Through study completion, an average of 5 days

• Symptoms Improvement

  Through study completion, an average of 5 days

• Hospital Stays

  Through study completion, an average of 5 days

Study Arms (3)

Control group: Received traditional treatment

NO INTERVENTION

Control group: received traditional treatment, intravenous injection of furosemide, aminophylline, dexamethasone, oxygen inhalation, and other symptomatic treatment drugs.

Inhaled Nitric Oxide (iNO) - Group A

EXPERIMENTAL

On the basis of traditional treatment, NO 15 ppm was inhaled 30min/ time, twice/day, once in the morning and once in the afternoon.

Device: Nitric Oxide Generation and Delivery System

Inhaled Nitric Oxide (iNO)-Group B

EXPERIMENTAL

On the basis of traditional treatment, NO 15 ppm was inhaled 2h/ time, twice/day, once in the morning and once in the afternoon.

Device: Nitric Oxide Generation and Delivery System

Interventions

Nitric Oxide Generation and Delivery System DEVICE

The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.

Inhaled Nitric Oxide (iNO) - Group A; Inhaled Nitric Oxide (iNO)-Group B

Eligibility Criteria

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

You may qualify 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 both lungs.
• Capacity to provide informed consent in accordance with local regulatory requirements.

You may not qualify 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%.
• 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.

Sponsors & Collaborators

• Novlead Inc.: lead
• Tibet Fokind Hospital: collaborator

Study Sites (1)

Tibet Fokang Hospital

Lhasa, Tibet, China

RECRUITING

MeSH Terms

Conditions

Pulmonary edema of mountaineers

Study Officials

• Jingxin Cao

  Tibet Fokind Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhou Fang

CONTACT

15655595707; zhou.fang@novlead.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 28, 2025
• Study Start: August 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)