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

NCT03736668 | Unknown DMC

• 1 other identifier: DIACAR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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%).

  year 1

Secondary Outcomes (6)

• Evaluation of the modification of left ventricular function

  year 1

• Occurrence of major or fatal events, or cardiovascular events

  year 1

• Occurrence of major fatal 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).

  year 1

• Comparison of inter- and intra-observer variability in a sample of 20 patients in the cohort of 200 patients

  Year 1

Study Arms (1)

Patients with Type 2 diabetes

EXPERIMENTAL

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.

Diagnostic Test: echocardiography

Interventions

echocardiography DIAGNOSTIC_TEST

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.

Patients with Type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Yara P ANTAKLY, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 9, 2018
• Study Start: May 22, 2018
• Primary Completion: July 23, 2019
• Study Completion: December 30, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)