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Incretin and CRTd.

Primary Purpose

Type 2 Diabetes Mellitus, Heart Failure

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Incretin Effect

Cardiac Resynchronization therapy defibrillator device

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Raffaele Marfella

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

incretin arm

conventional hypoglycemic drug arm

Arm Description

T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

T2DM with HF treated by CRTd participants will be assigned prospectively to placebo comparator (placebo plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

Outcomes

Primary Outcome Measures

all cause mortality, and cardiac cause mortality.

Secondary Outcome Measures

hospital admissions for HF

Full Information

NCT ID

NCT03282136

First Posted

September 12, 2017

Last Updated

September 12, 2017

Sponsor

University of Campania "Luigi Vanvitelli"

1. Study Identification

Unique Protocol Identification Number

NCT03282136

Brief Title

Incretin and CRTd.

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

September 1, 2017 (Actual)

Study Completion Date

September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campania "Luigi Vanvitelli"

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

incretin arm

Arm Type

Active Comparator

Arm Description

Arm Title

conventional hypoglycemic drug arm

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Incretin Effect

Intervention Description

The patients will receive incretins therapy.

Intervention Type

Device

Intervention Name(s)

Cardiac Resynchronization therapy defibrillator device

Intervention Description

The patients will receive a Cardiac Resynchronization therapy defibrillator device

Primary Outcome Measure Information:

Title

all cause mortality, and cardiac cause mortality.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

hospital admissions for HF

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Raffaele Marfella

City

Naples

ZIP/Postal Code

80128

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30348145

Citation

Sardu C, Paolisso P, Sacra C, Santamaria M, de Lucia C, Ruocco A, Mauro C, Paolisso G, Rizzo MR, Barbieri M, Marfella R. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate. Cardiovasc Diabetol. 2018 Oct 22;17(1):137. doi: 10.1186/s12933-018-0778-9.

Results Reference

derived

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Incretin and CRTd.

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