SGLT2i and Incretin and CRTd.

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Heart Failure
• Interventions: Drug: Incretin Effect; Drug: SGLT-2 inhibitor; Device: Cardiac Resynchronization therapy defibrillator device

• Registration Number: NCT03282136
• Lead Sponsor: University of Campania Luigi Vanvitelli

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-01
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.

Exclusion Criteria

• T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
incretin arm	Incretin Effect	T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
incretin arm	Cardiac Resynchronization therapy defibrillator device	T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
conventional hypoglycemic drug arm	Cardiac Resynchronization therapy defibrillator device	T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
Incretin added to SGLT2i	SGLT-2 inhibitor	T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i added to incretin therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

Primary Outcome Measures

Name	Time	Method
all cause mortality, and cardiac cause mortality.	12 months
CRT responders	12 months

Secondary Outcome Measures

Name	Time	Method
hospital admissions for HF	12 months

Trial Locations

Locations (1)

Raffaele Marfella; 🇮🇹 Naples, Italy