High Altitude Pulmonary HypertensionHAPENCT06852924
Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)
A study testing Nitric Oxide Generation and Delivery System in people with High Altitude Pulmonary Hypertension, run by Novlead Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Altitude Pulmonary Hypertension
- What is being tested?
- Nitric Oxide Generation and Delivery System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tibet Fokang Hospital
Lhasa, Tibet
Jingxin Cao
About this study
Official title: A Single-center Prospective Randomized Controlled Trial of Inhaled Nitric Oxide in the Treatment of High Amplitude Pulmonary Edema(HAPE)
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.
Read the detailed description
This study utilized the inaugural nitric oxide therapeutic device sanctioned by the State Drug Administration, which possesses independent intellectual property rights (INOwill N300, Nanjing Novlead Biotechnology Co., LTD.). The device is compact and generates nitric oxide gas upon activation, eliminating the need for cylinders for the storage and transport of nitric oxide. It employs an electrochemical catalytic reduction method to produce nitric oxide gas in real-time and automatically administers the gas to the respiratory circuit at a predetermined concentration, based on flow monitoring. The phase change sensor sampling technology enables real-time monitoring of the concentrations of nitric oxide, nitrogen dioxide, and oxygen at the patient end of the respiratory circuit, thereby ensuring the safety of clinical interventions.
The primary aim of this investigation was to assess the efficacy of inhaled nitric oxide (iNO) in the management of mild to moderate high altitude pulmonary edema (HAPE) in comparison to a control group. Key parameters evaluated included the onset time of changes in oxygenation, the duration until symptom resolution (as measured by the Lake Louise Acute Mountain Sickness score), the time required for improvement in imaging indicators, and the proportions of patients categorized as cured, effective, ineffective, or experiencing severe HAPE by days 3 to 7 of treatment. Additionally, the length of hospital admission or stay was recorded for patients receiving iNO therapy for high altitude pulmonary edema. This study aimed to elucidate the impact of iNO on enhancing oxygenation and pulmonary circulation in patients with high altitude pulmonary edema relative to the control group.
- Conditions
- High Altitude Pulmonary Hypertension
- Being tested
- Nitric Oxide Generation and Delivery System
- Keywords
- iNO, HAPE
- Medical subject headings
- Pulmonary edema of mountaineers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide Generation and Delivery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nitric Oxide Generation and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Through study completion, an average of 5 days
Secondary outcomes (3)
Progression of HAPE
The proportion and time of HAPE cured, markedly effective, ineffective, or severe
Measured: Through study completion, an average of 5 days
Symptoms Improvement
Change of symptom improvement (Lake Louise AMS score, vital signs, imagings)
Measured: Through study completion, an average of 5 days
Hospital Stays
The length of hospital stay compared between groups
Measured: Through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novlead Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tibet Fokind Hospital
- Responsible party
- Sponsor
- Investigators
- Jingxin Cao, Principal investigator, Tibet Fokind Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852924
- Sponsor's protocol ID
- HAPE23-06
- Acronym
- HAPE
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Randomized Controlled Trial of Inhaled Nitric Oxide in the Treatment of High Amplitude Pulmonary Edema(HAPE)
- ClinicalTrials.gov ID
- NCT06852924
- Acronym / sponsor ID
- HAPE / HAPE23-06
- Conditions
- High Altitude Pulmonary Hypertension
- Keywords
- iNO, HAPE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novlead Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tibet Fokind Hospital
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study utilized the inaugural nitric oxide therapeutic device sanctioned by the State Drug Administration, which possesses independent intellectual property rights (INOwill N300, Nanjing Novlead Biotechnology Co., LTD.). The device is compact and generates nitric oxide gas upon activation, eliminating the need for cylinders for the storage and transport of nitric oxide. It employs an electrochemical catalytic reduction method to produce nitric oxide gas in real-time and automatically administers the gas to the respiratory circuit at a predetermined concentration, based on flow monitoring. The phase change sensor sampling technology enables real-time monitoring of the concentrations of nitric oxide, nitrogen dioxide, and oxygen at the patient end of the respiratory circuit, thereby ensuring the safety of clinical interventions.
The primary aim of this investigation was to assess the efficacy of inhaled nitric oxide (iNO) in the management of mild to moderate high altitude pulmonary edema (HAPE) in comparison to a control group. Key parameters evaluated included the onset time of changes in oxygenation, the duration until symptom resolution (as measured by the Lake Louise Acute Mountain Sickness score), the time required for improvement in imaging indicators, and the proportions of patients categorized as cured, effective, ineffective, or experiencing severe HAPE by days 3 to 7 of treatment. Additionally, the length of hospital admission or stay was recorded for patients receiving iNO therapy for high altitude pulmonary edema. This study aimed to elucidate the impact of iNO on enhancing oxygenation and pulmonary circulation in patients with high altitude pulmonary edema relative to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Nitric Oxide Generation and Delivery SystemOn the basis of traditional treatment, NO 15 ppm was inhaled 30min/ time, twice/day, once in the morning and once in the afternoon. |
| Inhaled Nitric Oxide (iNO)-Group B | Experimental | Device: Nitric Oxide Generation and Delivery SystemOn the basis of traditional treatment, NO 15 ppm was inhaled 2h/ time, twice/day, once in the morning and once in the afternoon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Confirmed contraindications for the use of nitric oxide include the following (refer to "5.3.4 NO Contraindications"):
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric Oxide Generation and Delivery SystemThe 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. | Device | Inhaled Nitric Oxide (iNO) - Group A, Inhaled Nitric Oxide (iNO)-Group B |
Primary outcome
Change of Oxygen Index
Time frame: Through study completion, an average of 5 days
The change of oxygenation index (PaO2 or SpO2/FiO2) from baseline, and the time required for oxygenation index to improve by ≥20%
3 secondary outcomes
Progression of HAPE
Time frame: Through study completion, an average of 5 days
Symptoms Improvement
Time frame: Through study completion, an average of 5 days
Hospital Stays
Time frame: Through study completion, an average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingxin Cao principal investigator
Tibet Fokind Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitric Oxide Generation and Delivery System in people with High Altitude Pulmonary Hypertension, run by Novlead Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou Fang (15655595707, zhou.fang@novlead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Oxygen Index (time frame: Through study completion, an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.