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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

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
GroupInterventionDescription
incretin armIncretin EffectT2DM 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 armCardiac Resynchronization therapy defibrillator deviceT2DM 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 armCardiac Resynchronization therapy defibrillator deviceT2DM 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 SGLT2iSGLT-2 inhibitorT2DM 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
NameTimeMethod
all cause mortality, and cardiac cause mortality.12 months
CRT responders12 months
Secondary Outcome Measures
NameTimeMethod
hospital admissions for HF12 months

Trial Locations

Locations (1)

Raffaele Marfella

🇮🇹

Naples, Italy

Raffaele Marfella
🇮🇹Naples, Italy

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