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Incretin and CRTd.

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ClinicalTrials.gov Identifier: NCT03282136
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Heart Failure Drug: Incretin Effect Device: Cardiac Resynchronization therapy defibrillator device Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: incretin arm
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.
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

Placebo Comparator: conventional hypoglycemic drug arm
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.
Device: Cardiac Resynchronization therapy defibrillator device
The patients will receive a Cardiac Resynchronization therapy defibrillator device




Primary Outcome Measures :
  1. all cause mortality, and cardiac cause mortality. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. hospital admissions for HF [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282136


Locations
Italy
Raffaele Marfella
Naples, Italy, 80128
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celestino Sardu, principal investigator, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03282136     History of Changes
Other Study ID Numbers: University of Campania
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Incretins
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists