SGLT2i and Incretin and CRTd.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2024-09-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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incretin arm

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.

Group Type ACTIVE_COMPARATOR

Incretin Effect

Intervention Type DRUG

The patients will receive incretins therapy.

Cardiac Resynchronization therapy defibrillator device

Intervention Type DEVICE

The patients will receive a Cardiac Resynchronization therapy defibrillator device

conventional hypoglycemic drug arm

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.

Group Type PLACEBO_COMPARATOR

Cardiac Resynchronization therapy defibrillator device

Intervention Type DEVICE

The patients will receive a Cardiac Resynchronization therapy defibrillator device

Incretin added to SGLT2i

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.

Group Type ACTIVE_COMPARATOR

SGLT-2 inhibitor

Intervention Type DRUG

The patients will receive SGLT2i therapy.

Interventions

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Incretin Effect

The patients will receive incretins therapy.

Intervention Type DRUG

Cardiac Resynchronization therapy defibrillator device

The patients will receive a Cardiac Resynchronization therapy defibrillator device

Intervention Type DEVICE

SGLT-2 inhibitor

The patients will receive SGLT2i therapy.

Intervention Type DRUG

Eligibility Criteria

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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.