Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention
NCT ID: NCT04806633
Last Updated: 2021-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
1722 participants
INTERVENTIONAL
2021-04-01
2023-12-01
Brief Summary
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Inhibitors 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.
These 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Dapagliflozin
Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI
Dapagliflozin 5mg
Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily.
Placebo
Patients who will be randomized to receive placebo following cardiac catheterization and PCI
Placebo
Patients randomized in this arm will receive placebo.
Interventions
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Dapagliflozin 5mg
Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily.
Placebo
Patients randomized in this arm will receive placebo.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 \[CKD stage G1-G3\]
* Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
Exclusion Criteria
* Participation in other intervention study
* Class I or equivalent indication for treatment with a SGLT2 inhibitor
* Pregnancy or willing of pregnancy during the follow up period
* Active urogenital infection
* Diabetes mellitus type 1
* History of diabetic ketoacidosis
* Cardiogenic shock
* eGFR \< 29 ml/min/1.73m2
* Patients with an indication for SGLT2 inhibitor will be included in a prospective registry. Their treatment will be determined by their attending physicians.
18 Years
100 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
G.Gennimatas General Hospital
OTHER
Responsible Party
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Spyridon Deftereos
Professor
Principal Investigators
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Spyridon Deftereos, Prof.
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece
Locations
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Cardiology Department, Athens General Hospital "G. Gennimatas"
Athens, , Greece
2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.
Athens, , Greece
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2663
Identifier Type: -
Identifier Source: org_study_id
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