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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03282136
Other study ID # University of Campania
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2017
Last updated September 12, 2017
Start date September 1, 2017
Est. completion date September 1, 2017

Study information

Verified date September 2017
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Intervention

Drug:
Incretin Effect
The patients will receive incretins therapy.
Device:
Cardiac Resynchronization therapy defibrillator device
The patients will receive a Cardiac Resynchronization therapy defibrillator device

Locations

Country Name City State
Italy Raffaele Marfella Naples

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality, and cardiac cause mortality. 12 months
Secondary hospital admissions for HF 12 months
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