SGLT2i and Incretin and CRTd.
- Conditions
- Type 2 Diabetes MellitusHeart Failure
- Interventions
- Drug: Incretin EffectDrug: SGLT-2 inhibitorDevice: 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.
- 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
Raffaele Marfella🇮🇹Naples, Italy