Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

NCT06249633 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STUDY00001807
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 elevated pulmonary artery pressure.

Conditions

Acute Respiratory Distress Syndrome; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Approximately 4 days

Secondary Outcomes (2)

• Improvement in urine output in response to iNO

  Approximately 4 days

• Improvement in serum creatinine in response to iNO

  Approximately 4 days

Study Arms (1)

iNOMAX

EXPERIMENTAL

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

Inhaled nitric oxide

Also known as: iNOMAX

iNOMAX

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ARDS based on the Berlin criteria
• Mechanically ventilated
• Age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuri Matusov: lead
• Mallinckrodt: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypertension, Pulmonary

Interventions

Nitric Oxide; Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yuri Matusov, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Gholian

CONTACT

310-423-8474; grouplungresearch@cshs.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

US (1)