Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-01 @ 1:29 PM
Study NCT ID:
NCT06181968
Status:
WITHDRAWN
Last Update Posted:
2024-03-07
First Post:
2023-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Treatment in Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the treating physician on the ward will know which arm the patient belongs to'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled, blinded'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI not workining at KUH anymore.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with re-hospitalization or death', 'timeFrame': '6-months, also 3-months will be analyzed', 'description': 'post-discharge combined endpoint of re-hospitalization for acute heart failure or death due to any cause'}, {'measure': 'Number of patients with re-hospitalization', 'timeFrame': '6-months, also 3-months will be analyzed', 'description': 'Post-discharge re-hospitalization due to acute heart failure'}], 'secondaryOutcomes': [{'measure': 'Number of patients with decongestion', 'timeFrame': 'during hospitalization', 'description': 'Decongestion as measured by multiple congestion parameters, i.e. reduction in cardiac filling pressures and pulmonary congestion on ultrasound, fluid/weight loss, reduction in natriuretic peptides, symptom improvement, length of hospitalization, adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Heart Failure', 'Echocardiography', 'Lung Ultrasound'], 'conditions': ['Acute Heart Failure', 'Congestion']}, 'descriptionModule': {'briefSummary': 'A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.', 'detailedDescription': 'Study overview:\n\nThe purpose of this study is to evaluate whether ultrasound-guided decongestive therapy, guided by a focused thoracic ultrasound protocol combining echocardiography and lung ultrasound, could result in better decongestion and post-discharge prognosis without lengthening hospitalizations in hospitalized Acute Heart Failure patients.\n\nPrimary objectives:\n\nTo test whether ultrasound-guided therapy could result in reduced 6-month post-discharge mortality rates or re-hospitalization rates\n\nSecondary objectives:\n\nTo test whether ultrassound-guided therapy could result in greater decongestion as defined by various congestion parameters, i.e. ultrasound-derived cardiac filling pressures on echocardiography, pulmonary congestion on lung ultrasound, reduction in natriuretic peptides and symptoms, fluid loss etc, and if this can be done without an increase in adverse events or and increase in length of hospitalizations.\n\nStudy Design and population:\n\nECHO-AHF is a non-blinded, randomized trial which will be conducted in 3-5 centers across Europe. Patients entering the ED between 8 am and 5 pm, monday to friady, and who fulfill study criteria will be enrolled and randomized in a 1:1-fashion\n\nInclusion criteria will consist of: Age 18 years or older and dyspnea at rest or orthophnea, BNP \\>400ng/l or a BNP \\>100ng/l AND signs of elevated LVEDP on echocardiography and multiple bilateral B-lines on LUS,. Dyspnea on excertion will not be sufficient for enrolment.\n\nExclusion criteria will consist of: Pulmonary fibrosis, Mental confusion, Chronic dialysis, Pregnancy/breastfeeding, Prisoners, Patient under involuntary treatment, Decision on study participation not made within 6 hours after receiving information regarding the study.\n\nEstimated population size based on power calculation will be approximately 120 patients in total.\n\nInvestigational therapy in the treatment group:\n\nPatients randomized to the treatment arm will receive ultrasound-guided therapy based on a focused ultrasound exam done on a daily basis except for saturdays and sundays, and their treatment will be intensified according to a pre-specified, guideline-based treatment protocol, if the daily ultrasound protocol finds them congestive. Patients in the control arm will receive guideline-based conventional decongestive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple bilateral B-lines as a sign of interstitial syndrome on lung ultrasound\n* Elevated natriuretic peptide level\n* Signs of elevated LVEDP on echocardiography\n* Dyspnea at rest or ortophnea\n\nExclusion Criteria:\n\n* eGFR \\<25ml/min/1.73m2 or on dialysis\n* Altered mental orientation\n* Intubated\n* Mitral stenosis or previous mitral valve procedure\n* Chronic pulmonary parenchymal disease Pregnancy/breastfeeding\n* Prisoners\n* Patient under involuntary treatment\n* Decision on study participation not made within 6 hours after receiving information regarding the study'}, 'identificationModule': {'nctId': 'NCT06181968', 'acronym': 'ECHO-AHF', 'briefTitle': 'Ultrasound-guided Treatment in Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Echocardiography and Lung Ultrasound Combined Into a Rapid Cardiothoracic Ultrasound Protocol (CaTUS) for Guiding Decongestive Treartment on a Day-to-day Basis in Patients Hospitalized for Acute Heart Failure With Pulmonary Congestion', 'orgStudyIdInfo': {'id': 'KUH5101120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment arm', 'description': 'Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound', 'interventionNames': ['Diagnostic Test: Cardiothoracic ultrasound protocol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Arm', 'description': 'This arm will have the same ultrasound exams done daily as the treatment arm, but information will not be available for the treating physician for guiding therapy', 'interventionNames': ['Diagnostic Test: Cardiothoracic ultrasound protocol']}], 'interventions': [{'name': 'Cardiothoracic ultrasound protocol', 'type': 'DIAGNOSTIC_TEST', 'description': 'Combined echocardiography and lung ultrasound for guiding therapy', 'armGroupLabels': ['Control Arm', 'Treatment arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Juha Hartikainen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}