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OpenTrials
Completed

NCT Number: NCT03282136

SGLT2i and Incretin and CRTd.

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Raffaele Marfella

Naples, Italy, 80128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Incretin Effect

Drug

The patients will receive incretins therapy.

Cardiac Resynchronization therapy defibrillator device

Device

The patients will receive a Cardiac Resynchronization therapy defibrillator device

SGLT-2 inhibitor

Drug

The patients will receive SGLT2i therapy.

Primary outcomes

  1. all cause mortality, and cardiac cause mortality.

    Time frame: 12 months

  2. CRT responders

    Time frame: 12 months

Secondary outcomes

  1. hospital admissions for HF

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Incretin Treatment and Combined to SGLT2i Effect in Type 2 Diabetes Mellitus Patients Affected by Heart Failure With Depressed Ejection Fraction, and Treated by Cardiac Resynchronization Therapy With a Defibrillator.

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2017
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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