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

Type2 Diabetes Clinical Trial

— DIACAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736668
• Other study ID #: DIACAR
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%).	year 1
Secondary	Occurrence of major or fatal events, or cardiovascular events	The investigator will collect major or fatal events, or cardiovascular events.	year 1
Secondary	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.	year 2
Secondary	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.	year 1
Secondary	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.	Year 1
Secondary	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.	Year 1