Incretin and CRTd.

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282136
• Other study ID #: University of Campania
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes Mellitus

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