A Phase 4 interventional study of Incretin Effect and Cardiac Resynchronization therapy defibrillator device in Type 2 Diabetes Mellitus and Heart Failure, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by University of Campania Luigi Vanvitelli · Phase 4, Interventional, and Treatment
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).
Exclusion Criteria:
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.
Drug: Incretin Effect · Device: 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.
Device: Cardiac Resynchronization therapy defibrillator device
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.
Drug: SGLT-2 inhibitor
The patients will receive incretins therapy.
The patients will receive a Cardiac Resynchronization therapy defibrillator device
The patients will receive SGLT2i therapy.
all cause mortality, and cardiac cause mortality.
Time frame: 12 months
CRT responders
Time frame: 12 months
hospital admissions for HF
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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University of Campania Luigi Vanvitelli