Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 5:22 PM
Study NCT ID:
NCT06249633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}, {'id': 'D045462', 'term': 'Endothelium-Dependent Relaxing Factors'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014665', 'term': 'Vasodilator Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determining improvement in pulmonary artery pressure in response to iNO', 'timeFrame': 'Approximately 4 days', 'description': 'Pulmonary artery systolic pressure (in mmHg) will be determined by repeat echocardiography after initiation of iNO.'}, {'measure': 'Determining improvement in tricuspid annular plane systolic excursion in response to iNO', 'timeFrame': 'Approximately 4 days', 'description': 'Changes in tricuspid annular plane systolic excursion (in cm) will be determined by repeat echocardiography after initiation of iNO.'}, {'measure': 'Determining improvement in right ventricular fractional area change in response to iNO', 'timeFrame': 'Approximately 4 days', 'description': 'Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO.'}], 'secondaryOutcomes': [{'measure': 'Improvement in urine output in response to iNO', 'timeFrame': 'Approximately 4 days', 'description': 'Urine output changes will be determined by continuous bedside evaluation of urine output (in ml/hr) before and after initiation of iNO.'}, {'measure': 'Improvement in serum creatinine in response to iNO', 'timeFrame': 'Approximately 4 days', 'description': 'Changes in serum creatinine (in mg/dL) will be determined by laboratory analysis following initiation of iNO.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ARDS based on the Berlin criteria\n* Mechanically ventilated\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Primary cardiogenic shock\n* History of more than mild pulmonary hypertension preceding ARDS diagnosis\n* Presence of pre-existing significant valvular disease\n* Presence of pre-existing left ventricular dysfunction or significant hypertrophy\n* Consent cannot be obtained from the patient or his/her surrogates\n* Refusal of consent\n* Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome'}, 'identificationModule': {'nctId': 'NCT06249633', 'briefTitle': 'Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'STUDY00001807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iNOMAX', 'interventionNames': ['Drug: Nitric Oxide']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'otherNames': ['iNOMAX'], 'description': 'Inhaled nitric oxide', 'armGroupLabels': ['iNOMAX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Emine Gholian', 'role': 'CONTACT', 'email': 'grouplungresearch@cshs.org'}, {'name': 'Yuri Matusov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Emine Gholian', 'role': 'CONTACT', 'email': 'grouplungresearch@cshs.org', 'phone': '310-423-8474'}], 'overallOfficials': [{'name': 'Yuri Matusov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuri Matusov', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yuri Matusov', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}