Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT05849766
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D017257', 'term': 'Ramipril'}, {'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-05-07', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures', 'timeFrame': '6 months', 'description': 'Change in median / mean of EROA before and after drug administration'}], 'secondaryOutcomes': [{'measure': 'Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures', 'timeFrame': '6 months', 'description': 'Change in median / mean of LVEF before and after drug administration'}, {'measure': 'Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients', 'timeFrame': '6 months', 'description': 'Change in median / mean of ProBNP before and after drug administration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dilated Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'A significant reduction in the incidence of CV death or hospitalization for HF has been observed in randomized trials investigating the CV benefit of Dapagliflozin. Mechanistic investigations are required to interpret the positive clinical effects of Dapagliflozin on heart structure and valvular regurgitation.', 'detailedDescription': 'A functional mitral regurgitation (MR) occurs when the mitral valve (MV) becomes tethered due to abnormal LV remodelling in individuals with heart failure (HF) and left ventricular (LV) dilatation.\n\nThe primary treatment for HF is medical, and it is based on established guidelines, as LV failure is the most common cause of secondary functional MR. Standard medical therapy for patients with functional MR, including beta blockers, ACE inhibitors, and angiotensin receptor blockers (ARB), does not reduce the morbidity or mortality associated with these conditions.\n\nSimilar to the neprilysin inhibitor, which promotes sodium excretion and has vasodilatory effects via relaxing blood vessels, Dapagliflozin reduce cardiac preload and afterload by inducing natriuresis and reducing arterial stiffness. Effects on blood pressure reduction and weight loss may also positively affect left ventricular (LV) remodelling.\n\nUsing echocardiography, researchers hope to test the hypothesis that dapagliflozin improves MR in patients with functional MR due to LV dysfunction. This hypothesis is based on studies showing the beneficial effects of Dapagliflozin on LV modelling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients ≥ 18 years of age\n* Dilated LV with a reduced ejection fraction and secondary functional MR\n* NYHA functional class II or III\n* Moderate to Severe MR which lasted \\> 6 months under medical treatment with a β-blocker and an ACE inhibitor (or ARB)\n\nExclusion Criteria:\n\n* Current use or prior use of Dapagliflozin\n* Current acute heart failure or prior admission with acute decompensated heart failure in 6 months before entry to study\n* NYHA functional class IV\n* Chronic renal impairment with GFR \\< 30 mL/min/1.73m2\n* Pregnant or lactating women\n* History of allergy to Dapagliflozin'}, 'identificationModule': {'nctId': 'NCT05849766', 'briefTitle': 'Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction', 'orgStudyIdInfo': {'id': 'IHC00044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Group 1 received only standard therapy ACE/ ARB, BB, and diuretics', 'interventionNames': ['Drug: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®']}, {'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics', 'interventionNames': ['Drug: Dapagliflozin Farxiga®']}], 'interventions': [{'name': 'Dapagliflozin Farxiga®', 'type': 'DRUG', 'otherNames': ['Forxiga'], 'description': 'Dapagliflozin 10 mg once daily', 'armGroupLabels': ['Interventional']}, {'name': 'Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®', 'type': 'DRUG', 'otherNames': ['Tritace, Carvid, Aldactone'], 'description': 'Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Beni-suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'overallOfficials': [{'name': 'Ahmed Essam Abou Warda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'October 6 University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart Institute, Egypt', 'class': 'OTHER_GOV'}, {'name': 'University of Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Ahmed Essam', 'investigatorAffiliation': 'October 6 University'}}}}