Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-26 @ 2:25 PM
Study NCT ID:
NCT05613218
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2022-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Oxygen-delivery will be given through a robot, which adjusts oxygen-flow towards a given oxygen-saturation target. The robots monitor will be turned of during the intervention and will only alarm in case of clinically relevant hypoxemia.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 allocation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary parenchymal fluid content after 24 hours', 'timeFrame': '24 hours', 'description': 'Pulmonary parenchymal fluid content after 24 hours preceded by 10 minutes without oxygen-supplementation assessed noninvasively by the remote dielectric sensing (ReDS) device (Sensible Medical, Netanya, Israel)'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days', 'description': 'Death from all causes'}, {'measure': 'Days alive out-of-hospital', 'timeFrame': '30 days'}, {'measure': 'Time to freedom from oxygen-supplementation', 'timeFrame': '48 hours'}, {'measure': '4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission.', 'timeFrame': '24 hours'}, {'measure': '5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation.', 'timeFrame': '24 hours'}, {'measure': 'Tricuspid annular plane systolic excursion', 'timeFrame': '24 hours'}, {'measure': 'Global longitudinal strain of the right ventricle', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute heart failure', 'Pulmonary edema', 'Oxygen', 'Pulmonary congestion'], 'conditions': ['Acute Heart Failure', 'Pulmonary Congestion', 'Hypoxemia']}, 'descriptionModule': {'briefSummary': 'This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion.\n\nPatients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.\n\n1. Liberal oxygenation group = SpO2 target of 96%.\n2. Restrictive oxygenation group = SpO2 target of 90%.\n\nThe allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC. The study will include 122 patients.', 'detailedDescription': 'Background:\n\nOne million hospitalizations occur each year with a primary diagnosis of acute heart failure in the USA, with comparable numbers in Europe. Most patients with acute heart failure are treated with supplemental oxygen during hospitalization and guidelines recommend initiation of oxygen therapy if SpO2 \\<90% (class I, level C). However, no clinical trials of oxygen targets in humans with acute heart failure investigating clinically relevant endpoints have been performed.\n\nPrimary objective:\n\nTo investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure.\n\nHypothesis:\n\nRestrictive oxygenation is associated with improved clinical outcome compared to liberal oxygenation.\n\nDesign: Investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial.\n\nIntervention:\n\nPatients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.\n\n1. Liberal oxygenation group = SpO2 target of 96%.\n2. Restrictive oxygenation group = SpO2 target of 90%.\n\nPatients will have nasal cannula or oxygen mask placed as the usual care, and oxygen is titrated to the prespecified target range.\n\nConsented patients will be randomly allocated to study groups via the automated web-based system within REDCap. The allocation will be concealed. Time at randomization will be considered as study time zero (T0). All patients will receive usual standard of care except for their oxygen-administration.\n\nThe intervention-phase will be 24 h, and hereafter oxygen therapy will be at the discretion of the treating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Acute (within minutes to days) onset or worsening of subjective dyspnea\n3. Oxygen saturation \\<92% (on arterial blood gas) or need of oxygen\n4. At least one of the following clinical or radiological signs of congestion:\n\n1\\. Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-lines\n\nExclusion Criteria:\n\n1. More than 4 hours from hospital admission to randomization\n2. Suspected infection or sepsis\n3. Known severe pulmonary disease\n4. Systolic blood pressure \\<90 mmHg'}, 'identificationModule': {'nctId': 'NCT05613218', 'acronym': 'REDOX-AHF', 'briefTitle': 'Oxygen Targets in Acute Heart Failure With Pulmonary Congestion', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial', 'orgStudyIdInfo': {'id': 'REDOX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal oxygenation group', 'description': 'SpO2 target of 96%', 'interventionNames': ['Drug: Oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restrictive oxygenation group', 'description': 'SpO2 target of 90%.', 'interventionNames': ['Drug: Oxygen']}], 'interventions': [{'name': 'Oxygen', 'type': 'DRUG', 'description': 'Patients will have nasal cannula or oxygen mask placed as the usual standard of care.\n\nPatients will be screened and randomized in the emergency department to either liberal or restrictive oxygenation after providing informed written consent and oxygen is titrated to the prespecified target range using an automated feedback device (O2MATIC). Consented patients will be randomly allocated to study groups via the web-based system within REDCap. The allocation will be concealed. Time at randomization will be considered as study time zero (T0). All patients will receive usual standard of care except for their O2 management. The intervention will last for 24 h. After 24 h, patients will be switched over to usual care for oxygen therapy. If the treating physician thinks, that the patient need another oxygenation target and it is thought to be harmful to continue with the allocated target, the intervention-phase can be stopped prematurely.', 'armGroupLabels': ['Liberal oxygenation group', 'Restrictive oxygenation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jens Jakob Thune, MD, DMSc', 'role': 'CONTACT'}, {'name': 'Jens jakob Thune, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2650', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Johannes Grand', 'role': 'CONTACT', 'email': 'johannes.grand@regionh.dk'}], 'facility': 'Amager-Hvidovre Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Johannes Grand, MD, Phd', 'role': 'CONTACT', 'email': 'johannes.grand@regionh.dk', 'phone': '+4535453545'}, {'name': 'Ida Taraldsen, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Jens Hove, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Copenhagen University Hospital Amager-Hvidovre Department of Cardiology'}, {'name': 'Johannes Grand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital Amager-Hvidovre Department of Cardiology'}, {'name': 'Ida Taraldsen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Copenhagen University Hospital Amager-Hvidovre Department of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bispebjerg Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Johannes Grand', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}