NCT03736668

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%)

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	echocardiography	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.

Timeline

• Start date: 2018-05-22
• Primary completion: 2019-07-23
• Completion: 2023-12-30
• First posted: 2018-11-09
• Last updated: 2023-04-27

Locations

1 site across 1 country: France