Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention
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| ClinicalTrials.gov Identifier: NCT04806633 |
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Recruitment Status :
Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
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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.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Left Cardiac Catheterization Percutaneous Coronary Intervention Acute Kidney Injury Sodium-glucose Co-transporter 2 Inhibitors | Drug: Dapagliflozin 5mg Drug: Placebo | Early Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1722 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention |
| Estimated Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | September 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Dapagliflozin
Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI
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Drug: Dapagliflozin 5mg
Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily. |
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Placebo Comparator: Placebo
Patients who will be randomized to receive placebo following cardiac catheterization and PCI
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Drug: Placebo
Patients randomized in this arm will receive placebo. |
- Comparison of incidence of acute kidney injury (AKI) between the two study arms [ Time Frame: 1 month ]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.
- Development of at least Stage 2 AKI (according to the KDIGO criteria), i.e. Increase in sCR>2.0-fold from baseline. [ Time Frame: 1 month ]
- 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. [ Time Frame: 1 month ]
- Incidence (cases per 100 patient-years)of diabetic ketoacidosis. [ Time Frame: 1 month ]Any episode of metabolic acidosis (pH<7.3) with decreased serum bicarbonate (<18mEq/ml) and
- Incidence (cases per 100 patient-years)of lower urinary tract infections [ Time Frame: 1 month ]
- Comparison of all cause mortality between the two groups [ Time Frame: 1 month ]
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age>18 years
- 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:
- Active malignancy
- 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
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806633
| Contact: Spyridon Deftereos, Prof. | spdeftereos@gmail.com | ||
| Contact: Georgios Giannopoulos, Prof. | +302107768132 | georgios.giannopolous@yale.edu |
| Greece | |
| Cardiology Department, Athens General Hospital "G. Gennimatas" | |
| Athens, Greece, 11527 | |
| 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece. | |
| Athens, Greece, 12462 | |
| Principal Investigator: | Spyridon Deftereos, Prof. | 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece |
| Responsible Party: | Spyridon Deftereos, Professor, G.Gennimatas General Hospital |
| ClinicalTrials.gov Identifier: | NCT04806633 |
| Other Study ID Numbers: |
2663 |
| First Posted: | March 19, 2021 Key Record Dates |
| Last Update Posted: | March 19, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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dapaglifozin iodinated contrast media Sodium-glucose Co-transporter 2 Inhibitors Acute Kidney Injury |
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Acute Kidney Injury Kidney Diseases Urologic Diseases Renal Insufficiency Dapagliflozin |
Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |