Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05406505
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2021-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dyspnea ( Visual analogue scale) (VAS)', 'timeFrame': 'From baseline to day 4', 'description': '• Comparing the area under the curve (AUC) of change in VAS dyspnea score. To do so, individual changes in VAS score will be visualized as a curve where the x-axis shows study day baseline to day 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups'}], 'secondaryOutcomes': [{'measure': 'Incidence of worsening heart failure (HF)', 'timeFrame': 'From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days', 'description': 'Defined as worsening signs and/or symptoms of HF that require IV inotropic therapy or admission to an intensive care unit or mechanical ventilatory, renal or circulatory support.'}, {'measure': 'All-cause death', 'timeFrame': '30 days from discharge', 'description': 'Difference in all cause mortality rate'}, {'measure': 'All-cause death', 'timeFrame': '60 days from discharge', 'description': 'Difference in all cause mortality rate'}, {'measure': 'Hospital readmission', 'timeFrame': '30 days from discharge', 'description': 'Difference between groups in rate of readmission after discharge for heart failure related reason'}, {'measure': 'Hospital readmission', 'timeFrame': '60 days from discharge', 'description': 'Difference between groups in rate of readmission after discharge for heart failure reason'}, {'measure': 'Urinary sodium 2 hours post randomization', 'timeFrame': '2 Hours', 'description': 'Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups'}, {'measure': 'Difference in serum levels of congestion biomarkers', 'timeFrame': '4 days post-randomization', 'description': 'Difference in serum levels of Nt-ProBNP 4 days post-randomization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic and non diabetic'], 'conditions': ['Acute Heart Failure']}, 'referencesModule': {'references': [{'pmid': '37923161', 'type': 'DERIVED', 'citation': 'Emara AN, Wadie M, Mansour NO, Shams MEE. The clinical outcomes of dapagliflozin in patients with acute heart failure: A randomized controlled trial (DAPA-RESPONSE-AHF). Eur J Pharmacol. 2023 Dec 15;961:176179. doi: 10.1016/j.ejphar.2023.176179. Epub 2023 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:\n\n \\* 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure \\> 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound.\n\n OR\n\n \\*If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.\n2. Randomized within 24 hours of hospitalization for AHF\n3. Planned use of IV loop diuretic therapy during current hospitalization\n4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation\n5. For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus.\n2. Dyspnea primarily due to non-cardiac causes.\n3. Cardiogenic shock.\n4. Acute coronary syndrome within 30 days prior to randomization.\n5. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.\n6. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\\>7.30 and glucose \\>15 mmol/L and HCO3\\>18 mmol/L).\n7. Pregnant or nursing (lactating) women.\n8. Heart failure due to drug toxicity\n9. Adherence to medication less than 95%'}, 'identificationModule': {'nctId': 'NCT05406505', 'briefTitle': 'Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effect of Adjuvant Dapagliflozin on Improving the Treatment of Congestion in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)', 'orgStudyIdInfo': {'id': '2022-61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozine 10mg', 'interventionNames': ['Drug: Dapagliflozin 10mg Tab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dapagliflozin 10mg Tab', 'type': 'DRUG', 'description': 'patients will receive once daily dapagliflozin 10 mg orally in addition to standard care', 'armGroupLabels': ['Dapagliflozine 10mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'patients will receive placebo and standard care.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Noha Mansour', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Noha Mansour, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura'}, {'name': 'Moheb Magdy Mouris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Faculty of Medicine, University of Mansoura'}, {'name': 'Mohamed El-Husseiny Shams, Proffesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Noha Mansour', 'investigatorAffiliation': 'Mansoura University'}}}}