NCT03282136

SGLT2i and Incretin and CRTd.

Incretin Treatment and Combined to SGLT2i Effect in Type 2 Diabetes Mellitus Patients Affected by Heart Failure With Depressed Ejection Fraction, and Treated by Cardiac Resynchronization Therapy With a Defibrillator.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).

Conditions

• Type 2 Diabetes Mellitus
• Heart Failure

Interventions

Type	Name	Description
DRUG	Incretin Effect	The patients will receive incretins therapy.
DEVICE	Cardiac Resynchronization therapy defibrillator device	The patients will receive a Cardiac Resynchronization therapy defibrillator device
DRUG	SGLT-2 inhibitor	The patients will receive SGLT2i therapy.

Timeline

• Start date: 2017-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2017-09-13
• Last updated: 2025-06-25

Locations

1 site across 1 country: Italy