SGLT2i and Incretin and CRTd.

University of Campania Luigi Vanvitelli

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Heart Failure

Treatments: Device: Cardiac Resynchronization therapy defibrillator device; Drug: SGLT-2 inhibitor; Drug: Incretin Effect

Study type: Interventional

Funder types: Other

Identifiers

NCT03282136

University of Campania

Details and patient eligibility

About

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).

Enrollment: 500 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 3 patient groups, including a placebo group

incretin arm

Active Comparator group

Description:

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.

Treatment:

Drug: Incretin Effect

Device: Cardiac Resynchronization therapy defibrillator device

conventional hypoglycemic drug arm

Placebo Comparator group

Description:

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.

Treatment:

Device: Cardiac Resynchronization therapy defibrillator device

Incretin added to SGLT2i

Active Comparator group

Description:

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.

Treatment:

Drug: SGLT-2 inhibitor