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Clinical Trials/NCT02956577
NCT02956577
Completed
N/A

Systolic and Diastolic Left Ventricular Function in Patients With Type 2 DIABetes Mellitus: Changes Over Time and Comparison With Cardiac Microcirculation. An ECHOcardiographic Study

Svendborg Hospital1 site in 1 country300 target enrollmentMarch 16, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Left Ventricular Dysfunction
Sponsor
Svendborg Hospital
Enrollment
300
Locations
1
Primary Endpoint
Changes in Global Longitudinal Strain (GLS) stratified by Coronary Artery Calcium Score (CAC) in patients with diabetes during one year of follow-up
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study was to investigate the influence of micro- and macrovascular changes on the cardiac function in relation to left ventricular function and coronary arteries during one year in patients with type 2 diabetes.

Detailed Description

The most frequent heart disease in patients with Type 2 Diabetes Mellitus (T2DM) is the premature development of coronary atherosclerosis, which often leads to overt ischemic heart disease (IHD). T2DM can lead to both cardiac dysfunction due to IHD or to diabetic cardiomyopathy. Diabetic cardiomyopathy is defined as an impairment of left ventricular (LV) function without overt obstructive coronary vessel disease. Diabetic cardiomyopathy has been associated with microvascular dysfunction, which leads to the inability of the heart to circulate blood effectively. The microvascular atherosclerotic changes are well known in patients with diabetes, such as impaired vision, kidney function and sensibility. The macrovascular atherosclerotic changes such as plaques in the coronary arteries are strongly associated with reduced left ventricular function. However, the relationship between micro- and macrovascular atherosclerotic changes and the impact on cardiac function is less certain. Estimation of cardiac function includes: Left Atrial (LA) Strain, LA Strain Rate (SR), LA Emptying Function (LAEF), LV Ejection Fraction (EF), Fractional Shortening (FS), Global Longitudinal Strain (GLS), Circumferential Strain (CS) and Radial Strain (RS), Strain Rate (SR), Peak Systolic Strain, Post Systolic Strain, Early mitral filling velocity (E), late mitral filling velocity (A), E/A ratio, Deceleration Time (DCT) of early mitral filling velocity, medial and lateral mitral velocities using tissue doppler (e' , a' and s'), E/e' ratio, Isovolumetric Relaxation Time (IVRT), Isovolumetric Closing Time (IVCT), Ejection Time (ET), Myocardial Performance Index (MPI) and Myocardial Work Index (MWI). In this study, participants will be consisting of non-diabetic subjects and patients with diabetes type 1 + 2. All of the participants have no history of myocardial infarction, heart failure and current symptoms of cardiac disease. The study population will undergo following examinations: 1. 12-lead electrocardiogram (ECG) 2. Urine- and blood samples. 3. Measurements of anthropometric data and vital parameters 4. Recording of medical history 5. 2D transthoracic echocardiography 6. Coronary flow velocity reserve (CFVR) with adenosine infusion. 7. Coronary computed tomography angiography (CCTA). 8. Free fractional reserve computed tomography (FFR-CT) The examinations will be repeated at follow-up (however non-diabetic subjects will only have 1 CCTA performed at baseline). The non-invasive FFR-CT will only be performed once in a subgroup of diabetic patients and non-diabetic subjects from November 2016 until May 2017.

Registry
clinicaltrials.gov
Start Date
March 16, 2016
End Date
September 20, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Svendborg Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gokulan Pararajasingam

MD, Ph.D-student

Svendborg Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in Global Longitudinal Strain (GLS) stratified by Coronary Artery Calcium Score (CAC) in patients with diabetes during one year of follow-up

Time Frame: baseline, 12 months

To evaluate the changes in GLS stratified by CAC during one year of follow-up in patients with diabetes compared to non-diabetic subjects

Secondary Outcomes

  • Changes in LV function stratified by CFVR(baseline, 12 months)
  • Changes in GLS stratified by Coronary Flow Velocity Reserve (CFVR) in patients with diabetes during one year of follow-up(baseline, 12 months)
  • Correlation between biomarkers and GLS stratified by CAC(12 months)
  • Correlation between CFVR and Free Fractional Reserve -Computed Tomography (FFR-CT)(baseline)
  • Correlation between GLS and FFR-CT(baseline)
  • Correlation between biomarkers and GLS stratified by CFVR(12 months)
  • Changes in LV function stratified by CAC(baseline, 12 months)
  • Changes in LV function stratified by micro- and macrovascular diabetic status(baseline, 12 months)
  • Changes in GLS in patients with long-term diabetes and no macrovascular disease(baseline)

Study Sites (1)

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