Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease (DIACAR)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is significantly increased by 30 to 40% in patients with acute or chronic heart failure with diabetes.

Systematic analysis of cardiac function is not currently proposed in international recommendations even though some antidiabetic drugs have been associated with an increased risk of heart failure in large randomized controlled trials or an increase in adverse events in proof-of-concept studies of heart failure with or without diabetes. Observational studies suggest that hypoglycemic sulfonamides may increase the risk of developing heart failure. In contrast, two sodium-glucose cotransporter type 2 inhibitors (empagliflozin and canagliflozin) have recently demonstrated a significant reduction in hospitalizations for heart failure in two large randomized controlled trials.

The detection of subclinical left ventricular dysfunction is therefore essential to better assess the risk of cardiac decompensation and to identify the existence of possible contraindications to the use of certain classes of drugs used in diabetes. Recent studies suggest that the left ventricular ejection fraction measured on three-dimensional acquisitions is a prognostic value index greater than the ejection fraction measured by Simpson biplane method in two-dimensional ultrasound. Similarly, it seems that the analysis of global longitudinal deformation is a prognostic factor superior to the analysis of the ejection fraction (two-dimensional or three-dimensional). The investigators will analyze these different parameters to confirm these data.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to analyze left ventricular function by echocardiography in a prospective cohort of 200 patients with type 2 diabetes and without known cardiac dysfunction and to search for possible differences in clinical profile depending on the presence and type of cardiac function's impairment.

Patients will be classified into four categories according to the left ventricular function:

  • Normal heart function
  • Altered ejection fraction (<40%)
  • Ejection fraction preserved (> 50%) with structural abnormality (left ventricular hypertrophy, left atrial dilatation) or diastolic dysfunction
  • Moderately impaired ejection fraction "mid range" (40 to 49%)

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with age > 18 years
  • Patient with type 2 diabetes with no history of proven cardiovascular disease
  • Patient hospitalizes In Diabetes Week Hospital (HDS)
  • Patient affiliated with a health insurance plan
  • Patient able to give free, informed and express consent

Exclusion Criteria:

  1. Patient with proven cardiovascular disease:

    • Acute coronary syndrome, revascularization of the myocardium, known and / or treated ischemic heart disease
    • Rhythmic disorders such as atrial fibrillation
    • Significant valvular disease known or treated by prosthetic valve
    • known and treated heart failure
    • Stroke
    • Symptomatic and / or revascularized arteritis
    • Pacemaker wearers
    • Cardiac Defibrillator Carriers
  2. Patient with progressive cancer
  3. Patient who has been treated with cardio-toxic chemotherapy or mediastinal radiotherapy
  4. Patient under tutorship / curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Type 2 diabetes

One year after patient's inclusion, during the additional cardiology consultation, an echocardiography will be performed by the investigator to evaluate any changes.

Two years after the patient's inclusion, an investigator will contact by phone the general practitioner, cardiologist and / or diabetologist treating the patient to find out if any cardiovascular events occurred.

One year after patient's inclusion, an echocardiography / doppler will be performed to evaluate any changes.Two years after the patient's inclusion, an investigating cardiologist will contact the physician, cardiologist and / or diabetologist treating the patient by telephone to find out if any cardiovascular events have occurred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of left ventricular ejection fraction
Time Frame: year 1
During the electrocardiography, the left ventricular function will be measured to look for possible differences depending on the type of impairment of cardiac function. Patients will be classified into 4 categories: normal cardiac function, altered ejection fraction (<40%), preserved ejection fraction (>50%) with structural abnormality or diastolic dysfunction, or ejection fraction mid range (40 to 49%).
year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the modification of left ventricular function
Time Frame: year 1
During the electrocardiography, the left ventricular ejection fraction will be measured to look for possible differences depending on the type of impairment of cardiac function. Patients will be classified into 4 categories: normal cardiac function, altered ejection fraction (<40%), preserved ejection fraction (>50%) with structural abnormality or diastolic dysfunction, or ejection fraction mid range (40 to 49%).
year 1
Occurrence of major or fatal events, or cardiovascular events
Time Frame: year 1
The investigator will collect major or fatal events, or cardiovascular events.
year 1
Occurrence of major fatal or cardiovascular events
Time Frame: year 2
The investigator will contact by phone patient's general practitioner, cardiologist or diabetologist to collect major or fatal events, or cardiovascular events.
year 2
Comparison of left ventricular ejection fraction measurements performed by biplane Simpson with those obtained from a 3D acquisition (Philips HeartModel).
Time Frame: year 1
During the electrocardiography, the left ventricular ejection fraction will be measured by biplane Simpson and a 3D acquisition. Then, the measurements will be compare.
year 1
Comparison of inter- and intra-observer variability in a sample of 20 patients in the cohort of 200 patients
Time Frame: Year 1
The mesaurement of left ventricular function will be compare in in a sample of 20 patients in the cohort of 200 patients between operators.
Year 1
Comparing the volume of the left atrium in Simpson biplane and in 3D
Time Frame: Year 1
During the echocardiography, the volume of the left atrium will be measure in Simpson biplane and in 3D and then the measurements will be compare.
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yara P ANTAKLY, MD, Groupe hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Actual)

July 23, 2019

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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