NCT04806633

Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention

Status unknown EARLY_PHASE1 Last updated 19 March 2021

What this trial tests

EARLY_PHASE1 trial testing Dapagliflozin 5mg in Left Cardiac Catheterization in 1,722 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
1 September 2023

1 December 2023

Quick facts

Lead sponsor	G.Gennimatas General Hospital
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,722
Start date	1 April 2021
Primary completion	1 September 2023
Estimated completion	1 December 2023
Sites	2 locations across Greece

Drugs / interventions tested

• Dapagliflozin 5mg — full drug profile →
• Placebo

Conditions studied

• Left Cardiac Catheterization — all drugs for Left Cardiac Catheterization →
• Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
• Acute Kidney Injury — all drugs for Acute Kidney Injury →
• Sodium-glucose Co-transporter 2 Inhibitors — all drugs for Sodium-glucose Co-transporter 2 Inhibitors →

Sponsor

G.Gennimatas General Hospital

Who can join

Adults 18 to 100, any sex, with Left Cardiac Catheterization or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Review of SGLT2i for the Treatment of Renal Complications: Experience in Patients with and Without T2D.
   González-Albarrán O, Morales C, Pérez-Maraver M, Aparicio-Sánchez JJ, et al · · 2022 · cited 8× · PMID 35704167 · DOI 10.1007/s13300-022-01276-2
2. The association between sodium-glucose cotransporter 2 inhibitors and contrast-associated acute kidney injury in patients with type 2 diabetes undergoing angiography: a propensity-matched study.
   Yang H, Yang L, Jardine MJ, Arnott C, et al · · 2024 · cited 3× · PMID 39719658 · DOI 10.1186/s40001-024-02214-7