NCT03282136CompletedPhase 4
SGLT2i and Incretin and CRTd.
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.
Source: ClinicalTrials.gov · Last updated 25 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (actual)
- First submitted
- 12 Sept 2017
- Start date
- 1 Sept 2017
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT03282136
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 500
- From 1 Sept 2017 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.
Who the study is looking for
- aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Raffaele Marfella Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.