Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-31 @ 4:44 PM
Study NCT ID:
NCT05717257
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to the treatment or control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2023-01-29', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': 'Absence of any suspected or confirmed adverse events or necessity of drug discontinuation'}, {'measure': 'Nt-proBNP', 'timeFrame': '1 year'}, {'measure': 'Systemic right ventricle fractional area change', 'timeFrame': '1 year'}, {'measure': 'Systemic right ventricle global longitudinal strain', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'dapagliflozin', 'systemic right ventricle'], 'conditions': ['Dapagliflozin Adverse Reaction', 'Efficacy', 'Systemic Right Ventricle']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.', 'detailedDescription': 'This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.\n\nDapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction.\n\nChanges in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18years\n* Optimal medical therapy or at least 3months\n* Systemic right ventricle ejection fraction≤40%, assessed on echocardiography\n\nExclusion Criteria:\n\n* Univentricular physiology\n* Systolic blood pressure\\<90mmHg\n* Glomerular filtration rate(GFR)\\<30ml/min'}, 'identificationModule': {'nctId': 'NCT05717257', 'acronym': 'DAPA-SERVE', 'briefTitle': 'Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)', 'organization': {'class': 'OTHER', 'fullName': 'Monaldi Hospital'}, 'officialTitle': 'Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction', 'interventionNames': ['Drug: Dapagliflozin 10mg Tab']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants assigned to this group will continue the standard optimized medical therapy'}], 'interventions': [{'name': 'Dapagliflozin 10mg Tab', 'type': 'DRUG', 'description': 'Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction', 'armGroupLabels': ['Dapagliflozin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80121', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavia Fusco, MD', 'role': 'CONTACT', 'email': 'flavia.fusco@ospedalideicolli.it', 'phone': '00390817064206'}], 'facility': 'Adult Congenital Heart Disease, Monaldi Hospital', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monaldi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Flavia Fusco', 'investigatorAffiliation': 'Monaldi Hospital'}}}}