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

Primary Purpose

Type2 Diabetes

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
echocardiography
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type2 Diabetes

Eligibility Criteria

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

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

Sites / Locations

  • Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Type 2 diabetes

Arm Description

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.

Outcomes

Primary Outcome Measures

Measurement of left ventricular ejection fraction
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%).

Secondary Outcome Measures

Evaluation of the modification of left ventricular function
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%).
Occurrence of major or fatal events, or cardiovascular events
The investigator will collect major or fatal events, or cardiovascular events.
Occurrence of major fatal or cardiovascular events
The investigator will contact by phone patient's general practitioner, cardiologist or diabetologist to collect major or fatal events, or cardiovascular events.
Comparison of left ventricular ejection fraction measurements performed by biplane Simpson with those obtained from a 3D acquisition (Philips HeartModel).
During the electrocardiography, the left ventricular ejection fraction will be measured by biplane Simpson and a 3D acquisition. Then, the measurements will be compare.
Comparison of inter- and intra-observer variability in a sample of 20 patients in the cohort of 200 patients
The mesaurement of left ventricular function will be compare in in a sample of 20 patients in the cohort of 200 patients between operators.
Comparing the volume of the left atrium in Simpson biplane and in 3D
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.

Full Information

First Posted
October 31, 2018
Last Updated
April 26, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03736668
Brief Title
Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease
Acronym
DIACAR
Official Title
Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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%)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Type 2 diabetes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
echocardiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of left ventricular ejection fraction
Description
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%).
Time Frame
year 1
Secondary Outcome Measure Information:
Title
Evaluation of the modification of left ventricular function
Description
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%).
Time Frame
year 1
Title
Occurrence of major or fatal events, or cardiovascular events
Description
The investigator will collect major or fatal events, or cardiovascular events.
Time Frame
year 1
Title
Occurrence of major fatal or cardiovascular events
Description
The investigator will contact by phone patient's general practitioner, cardiologist or diabetologist to collect major or fatal events, or cardiovascular events.
Time Frame
year 2
Title
Comparison of left ventricular ejection fraction measurements performed by biplane Simpson with those obtained from a 3D acquisition (Philips HeartModel).
Description
During the electrocardiography, the left ventricular ejection fraction will be measured by biplane Simpson and a 3D acquisition. Then, the measurements will be compare.
Time Frame
year 1
Title
Comparison of inter- and intra-observer variability in a sample of 20 patients in the cohort of 200 patients
Description
The mesaurement of left ventricular function will be compare in in a sample of 20 patients in the cohort of 200 patients between operators.
Time Frame
Year 1
Title
Comparing the volume of the left atrium in Simpson biplane and in 3D
Description
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.
Time Frame
Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Patient with progressive cancer Patient who has been treated with cardio-toxic chemotherapy or mediastinal radiotherapy Patient under tutorship / curatorship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yara P ANTAKLY, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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

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