Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT04806633
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2021-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1722}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence (cases per 100 patient-years) of hypoglycemia in both arms Any episode of hypoglycemia defined as serum glucose 60< mg/dl associated with symptoms of hypoglycemia.', 'timeFrame': '1 month'}, {'measure': 'Incidence (cases per 100 patient-years)of diabetic ketoacidosis.', 'timeFrame': '1 month', 'description': 'Any episode of metabolic acidosis (pH\\<7.3) with decreased serum bicarbonate (\\<18mEq/ml) and'}, {'measure': 'Incidence (cases per 100 patient-years)of lower urinary tract infections', 'timeFrame': '1 month'}, {'measure': 'Comparison of all cause mortality between the two groups', 'timeFrame': '1 month'}], 'primaryOutcomes': [{'measure': 'Comparison of incidence of acute kidney injury (AKI) between the two study arms', 'timeFrame': '1 month', 'description': 'AKI is defined defined as an absolute creatinine level increase of at least 0.3 mg/dL (≥26.5 μmol/L) or at least 1.5-fold from baseline.'}], 'secondaryOutcomes': [{'measure': 'Development of at least Stage 2 AKI (according to the KDIGO criteria), i.e. Increase in sCR>2.0-fold from baseline.', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dapaglifozin', 'iodinated contrast media', 'Sodium-glucose Co-transporter 2 Inhibitors', 'Acute Kidney Injury'], 'conditions': ['Left Cardiac Catheterization', 'Percutaneous Coronary Intervention', 'Acute Kidney Injury', 'Sodium-glucose Co-transporter 2 Inhibitors']}, 'referencesModule': {'references': [{'pmid': '24557146', 'type': 'RESULT', 'citation': 'Aurelio A, Durante A. Contrast-induced nephropathy in percutaneous coronary interventions: pathogenesis, risk factors, outcome, prevention and treatment. Cardiology. 2014;128(1):62-72. doi: 10.1159/000358042. Epub 2014 Feb 18.'}, {'pmid': '31212638', 'type': 'RESULT', 'citation': 'Garofalo C, Borrelli S, Liberti ME, Andreucci M, Conte G, Minutolo R, Provenzano M, De Nicola L. SGLT2 Inhibitors: Nephroprotective Efficacy and Side Effects. Medicina (Kaunas). 2019 Jun 11;55(6):268. doi: 10.3390/medicina55060268.'}, {'pmid': '27659469', 'type': 'RESULT', 'citation': 'McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.'}, {'pmid': '16177006', 'type': 'RESULT', 'citation': 'Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.'}, {'pmid': '32970396', 'type': 'RESULT', 'citation': 'Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.'}, {'pmid': '26158396', 'type': 'RESULT', 'citation': 'Ishibashi Y, Matsui T, Yamagishi S. Tofogliflozin, A Highly Selective Inhibitor of SGLT2 Blocks Proinflammatory and Proapoptotic Effects of Glucose Overload on Proximal Tubular Cells Partly by Suppressing Oxidative Stress Generation. Horm Metab Res. 2016 Mar;48(3):191-5. doi: 10.1055/s-0035-1555791. Epub 2015 Jul 9.'}, {'pmid': '27440829', 'type': 'RESULT', 'citation': 'Fioretto P, Zambon A, Rossato M, Busetto L, Vettor R. SGLT2 Inhibitors and the Diabetic Kidney. Diabetes Care. 2016 Aug;39 Suppl 2:S165-71. doi: 10.2337/dcS15-3006.'}]}, 'descriptionModule': {'briefSummary': 'Left heart catheterization and percutaneous coronary intervention (PCI) has become a useful tool in interventional cardiology, in which iodinated contrast media is used. Although the use of iodinated contrast media (CM) is considered to be safe in patients with normal renal function, it is risky in patients with known chronic renal insufficiency (CKD) and diabetes mellitus. Contrast induced nephropathy (CIN) remains one of the most leading causes of in hospital acute kidney injury (AKI), affecting morbidity and mortality. There are various mechanisms through which CM develop their nephrotoxic effects, including renal vasoconstriction and medullary hypoxia, tubular cell toxicity and reactive oxygen species formation.\n\nInhibitors of type 2 sodium- glucose co-transporter (SGLT2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. However, although SGLT2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. Moreover, pleiotropic effects have been observed, including a reno-protective action. In addition to the effects mediated by intrarenal hemodynamic changes, SGLT2-i also have direct anti-inflammatory and antifibrotic nephroprotective effects. Indeed, SGLT2-i suppress the production of reactive oxygen species, lessening glomerulosclerosis and tubulo-interstitial fibrosis.\n\nThese findings suggest that the use of SGLT2i could offer benefit by reducing/ preventing the nephrotoxic effects of contrast media leading to the assumption that the use of these drugs could prevent the incidence nephropathy after cardiac catheterization and percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years\n* Written informed consent\n* Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 \\[CKD stage G1-G3\\]\n* Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients\n\nExclusion Criteria:\n\n* Active malignancy\n* Participation in other intervention study\n* Class I or equivalent indication for treatment with a SGLT2 inhibitor\n* Pregnancy or willing of pregnancy during the follow up period\n* Active urogenital infection\n* Diabetes mellitus type 1\n* History of diabetic ketoacidosis\n* Cardiogenic shock\n* eGFR \\< 29 ml/min/1.73m2\n\n * Patients with an indication for SGLT2 inhibitor will be included in a prospective registry. Their treatment will be determined by their attending physicians.'}, 'identificationModule': {'nctId': 'NCT04806633', 'briefTitle': 'Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'G.Gennimatas General Hospital'}, 'officialTitle': 'Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '2663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin', 'description': 'Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI', 'interventionNames': ['Drug: Dapagliflozin 5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients who will be randomized to receive placebo following cardiac catheterization and PCI', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin 5mg', 'type': 'DRUG', 'description': 'Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily.', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients randomized in this arm will receive placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Cardiology Department, Athens General Hospital "G. Gennimatas"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Athens', 'country': 'Greece', 'facility': '2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Spyridon Deftereos, Prof.', 'role': 'CONTACT', 'email': 'spdeftereos@gmail.com'}, {'name': 'Georgios Giannopoulos, Prof.', 'role': 'CONTACT', 'email': 'georgios.giannopolous@yale.edu', 'phone': '+302107768132'}], 'overallOfficials': [{'name': 'Spyridon Deftereos, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G.Gennimatas General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Attikon Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Spyridon Deftereos', 'investigatorAffiliation': 'G.Gennimatas General Hospital'}}}}