Incretin and CRTd.

Phase 4

Completed

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

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

Brief Summary

Incretin therapy is a treatment for type 2 diabetes (T2DM) affected by heart failure (HF). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by Cardiac resynchronization therapy (CRT). These patients will randomly be treated by incretin v/s conventional hypoglicemic drugs. In this patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Incretin may reduce hospital admissions for HF in T2DM v/s conventional hypoglicemic drugs.

Detailed Description

Not available

Study Timeline

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

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
conventional hypoglycemic drug arm	Cardiac Resynchronization therapy defibrillator device	T2DM with HF treated by CRTd participants will be assigned prospectively to placebo comparator (placebo 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.
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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hospital admissions for HF	12 months

Trial Locations

Locations (1)

Raffaele Marfella; 🇮🇹 Naples, Italy