Type 2 Diabetes Mellitus, Heart Failure
Conditions
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).
Interventions
DRUGIncretin Effect
The patients will receive incretins therapy.
DEVICECardiac Resynchronization therapy defibrillator device
The patients will receive a Cardiac Resynchronization therapy defibrillator device
DRUGSGLT-2 inhibitor
The patients will receive SGLT2i therapy.
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality, and cardiac cause mortality. | 12 months |
| CRT responders | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| hospital admissions for HF | 12 months |
Countries
Italy
Outcome results
None listed