Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT05967156
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2023-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Empagliflozin in Heart Failure Dialysis Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2023-07-15', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Natriuretic Peptide', 'timeFrame': 'one month after administration', 'description': 'serum level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'Empagliflozin is not still approved for glomerular filtration rate \\< 20 cc/min/1.73m2. Considering the cardiac and renal benefits of this drug, the evaluation of the safety and efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.', 'detailedDescription': 'Heart failure dialysis patients with residual renal function will be followed up on Empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels, diuresis volume, and serum acidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure on dialysis with residual renal function\n\nExclusion Criteria:\n\n* Dialysis patients with no residual urine'}, 'identificationModule': {'nctId': 'NCT05967156', 'briefTitle': 'Empagliflozin in Heart Failure Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients', 'orgStudyIdInfo': {'id': 'SBMU--'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin', 'description': 'Heart failure dialysis patients will be treated with Empagliflozin', 'interventionNames': ['Drug: Empagliflozin10Mg Tab']}], 'interventions': [{'name': 'Empagliflozin10Mg Tab', 'type': 'DRUG', 'otherNames': ['Abide'], 'description': '10 mg daily', 'armGroupLabels': ['Empagliflozin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1666663421', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Nooshin Dalili', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Dalili', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMBU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'nooshin dalili', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}