NCT03977116

Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients

Completed Phase 4 Last updated 3 March 2020

What this trial tests

Phase 4 trial testing SLGT2 in Diabetes Mellitus in 100 participants. Completed in 1 March 2019.

Timeline

1 January 2017

Primary endpoint
1 January 2019

1 March 2019

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	100
Start date	1 January 2017
Primary completion	1 January 2019
Estimated completion	1 March 2019
Sites	1 location across Italy

Drugs / interventions tested

• SLGT2 — full drug profile →
• Placebo

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Heart Failure — all drugs for Heart Failure →
• Ventricular Arrythmia — all drugs for Ventricular Arrythmia →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). These patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. However, these patients are treated by implantable cardioverter defibrillator (ICD) and cardiac resynchronization with defbrillator devices (CRTd) implant. In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the ICD/CRTds' interventions, and to prevent mortality events in these' patients. On other hand, still a higher percentage of patients result as non responders to an ablative approach with higher acute and long term mortality rate. Therefore, in the present study in a population of HF patients (DM vs. non DM patients) affected by VA, authors will investigate the effects of CA on mortality rate at 12 months of follow up. In addition, authors would demonstrate the ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM. However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs. placebo. Indeed, study hypothesis will be that, a) DM vs. non DM patients might have higher mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of follow-up.

Publications & conference data

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

1. Sodium-glucose cotransporter 2 inhibitor effects on heart failure hospitalization and cardiac function: systematic review.
   Rasalam R, Atherton JJ, Deed G, Molloy-Bland M, et al · · 2021 · cited 16× · PMID 34219407 · DOI 10.1002/ehf2.13483
2. Redefining outcomes of ventricular arrhythmia for SGLT2 inhibitor medication in heart failure patients: a meta-analysis of randomized controlled trials.
   Lin M, Zhang S, Zhang L, Yang C, et al · · 2025 · cited 5× · PMID 39893467 · DOI 10.1186/s13643-025-02766-7