Acute Respiratory Distress SyndromeEarly Phase 1NCT06249633
Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
A Early Phase 1 study testing Nitric Oxide in people with Acute Respiratory Distress Syndrome and Pulmonary Hypertension, run by Yuri Matusov at 1 site in United States.
Trial summary
Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Pulmonary Hypertension
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2024to Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ARDS based on the Berlin criteria
- Mechanically ventilated
- Age ≥ 18 years
Who cannot join
- Primary cardiogenic shock
- History of more than mild pulmonary hypertension preceding ARDS diagnosis
- Presence of pre-existing significant valvular disease
- Presence of pre-existing left ventricular dysfunction or significant hypertrophy
- Consent cannot be obtained from the patient or his/her surrogates
- Refusal of consent
- Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Emine Gholian, grouplungresearch@cshs.org
Yuri Matusov, MD
About this study
Official title: A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.
- Being tested
- Nitric Oxide
- Medical subject headings
- Respiratory Distress Syndrome, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called iNOMAX
Inhaled nitric oxide
| Study group | Role | What they receive |
|---|---|---|
| iNOMAX | Experimental | Not described Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining improvement in pulmonary artery pressure in response to iNO
Pulmonary artery systolic pressure (in mmHg) will be determined by repeat echocardiography after initiation of iNO.
Measured: Approximately 4 days
Determining improvement in tricuspid annular plane systolic excursion in response to iNO
Changes in tricuspid annular plane systolic excursion (in cm) will be determined by repeat echocardiography after initiation of iNO.
Measured: Approximately 4 days
Determining improvement in right ventricular fractional area change in response to iNO
Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO.
Measured: Approximately 4 days
Secondary outcomes (2)
Improvement in urine output in response to iNO
Urine output changes will be determined by continuous bedside evaluation of urine output (in ml/hr) before and after initiation of iNO.
Measured: Approximately 4 days
Improvement in serum creatinine in response to iNO
Changes in serum creatinine (in mg/dL) will be determined by laboratory analysis following initiation of iNO.
Measured: Approximately 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuri Matusov
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Yuri Matusov, Cedars-Sinai Medical Center
- Investigators
- Yuri Matusov, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249633
- Sponsor's protocol ID
- STUDY00001807
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06249633
- Acronym / sponsor ID
- STUDY00001807
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yuri MatusovUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 8 Feb 2024 (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.
Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNOMAX | Experimental | Drug: Nitric Oxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of ARDS based on the Berlin criteria
- Mechanically ventilated
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Primary cardiogenic shock
- History of more than mild pulmonary hypertension preceding ARDS diagnosis
- Presence of pre-existing significant valvular disease
- Presence of pre-existing left ventricular dysfunction or significant hypertrophy
- Consent cannot be obtained from the patient or his/her surrogates
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 OxideAlso: iNOMAXInhaled nitric oxide | Drug | iNOMAX |
Primary outcome
Determining improvement in pulmonary artery pressure in response to iNO
Time frame: Approximately 4 days
Pulmonary artery systolic pressure (in mmHg) will be determined by repeat echocardiography after initiation of iNO.
Determining improvement in tricuspid annular plane systolic excursion in response to iNO
Time frame: Approximately 4 days
Changes in tricuspid annular plane systolic excursion (in cm) will be determined by repeat echocardiography after initiation of iNO.
Determining improvement in right ventricular fractional area change in response to iNO
Time frame: Approximately 4 days
Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO.
2 secondary outcomes
Improvement in urine output in response to iNO
Time frame: Approximately 4 days
Improvement in serum creatinine in response to iNO
Time frame: Approximately 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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. This study is not recruiting at the moment.
Yuri Matusov, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nitric Oxide in people with Acute Respiratory Distress Syndrome and Pulmonary Hypertension, run by Yuri Matusov at 1 site in United States.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emine Gholian (310-423-8474, grouplungresearch@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining improvement in pulmonary artery pressure in response to iNO (time frame: Approximately 4 days). The study lists 3 primary outcomes in all. 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 8 Feb 2024.