Cardiac Function and Microcirculation: Type 2 DIABetes and ECHOcardiographic Changes Over Time

Left Ventricular Dysfunction Clinical Trial

— DIABECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956577
• Other study ID #: OUHSVB001
• Status: Completed
• Start date: March 16, 2016
• Est. completion date: September 20, 2018

Study information

• Verified date: October 2018
• Source: Svendborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Ability to give informed consent

• Estimated glomerular filtration rate (eGFR) > 45 ml/min

• NYHA I + II

Exclusion criteria:

• 2° or 3° AV-block at baseline

• Long QT-syndrome at baseline

• Sinus node dysfunction with long sinus arrest at baseline

• Angina pectoris at baseline

• Ejection fraction (EF) < 40% at baseline

• Atrial fibrillation at baseline

• Usage of dipyridamol at baseline

• Aortic stenosis and left ventricle hypertrophia at baseline

• Aortic insufficiency and left ventricle dilatation at baseline

• Medication for asthma within the last 4 years prior to baseline

• Medication for chronic obstructive pulmonary disease (COPD) at baseline

• Allergy to contrast agent at baseline

• Significant stenosis in left main (LM) / left anterior descending (LAD) artery at baseline

• Not feasible to measure or perform coronary flow velocity reserve (CFVR)

• Poor quality of echocardiographic images

• History of pacemaker

• History of myocardial infarction (MI)

• History of heart failure (HF)

• History of coronary artery bypass grafting (CABG)

• History of aortic valve replacement

• History of atrial fibrillation

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
Denmark	Cardiovascular Research Unit, OUH Svendborg Hospital	Svendborg

Sponsors (1)

Lead Sponsor	Collaborator
Svendborg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between strain values and framerate	To evaluate the changes in strain values dependant of framerate	baseline, 12 months
Other	Relationship between strain values and omitted myocardial segments	To evaluate the changes in strain values dependant of number of myocardial segments omitted	baseline, 12 months
Other	Correlation between dysglycaemia and Left Ventricle Mass (LVM)	To evaluate the impact of dysglycaemia on LVM in non-diabetic subjects compared to diabetic patients.	Baseline
Other	Left Ventricle (LV) and Left Atrial (LA) function stratified by New York Heart Association (NYHA) functional class	To evaluate LV and LA systolic and diastolic function in relation to NYHA classification	baseline
Other	Changes in cardiac systolic and diastolic function stratified by CAC during five years of follow-up in patients with diabetes	To evaluate the changes in cardiac systolic and diastolic function stratified by CAC during five years of follow-up in patients with diabetes compared to non-diabetic subjects.	baseline, 60months
Other	Changes in cardiac systolic and diastolic function stratified by CFVR during five years of follow-up in patients with diabetes	To evaluate the changes in cardiac systolic and diastolic function stratified by CFVR during five years of follow-up in patients with diabetes compared to non-diabetic subjects.	baseline, 60months
Other	Changes in cardiac systolic and diastolic function stratified by plaque morphology during five years of follow-up in patients with diabetes	To evaluate the changes in cardiac systolic and diastolic function stratified by plaque morphology during five years of follow-up in patients with diabetes compared to non-diabetic subjects.	baseline, 60months
Other	LA function stratified by CFVR	To evaluate atrial function stratified by CFVR in patients with diabetes compared to non-diabetic subjects.	baseline
Other	LA function stratified by micro- and macrovascular status	To evaluate atrial function in relation to albuminuria, retinopathy, neuropathy, diabetes duration and CAC.	baseline
Primary	Changes in Global Longitudinal Strain (GLS) stratified by Coronary Artery Calcium Score (CAC) in patients with diabetes during one year of follow-up	To evaluate the changes in GLS stratified by CAC during one year of follow-up in patients with diabetes compared to non-diabetic subjects	baseline, 12 months
Secondary	Changes in GLS stratified by Coronary Flow Velocity Reserve (CFVR) in patients with diabetes during one year of follow-up	To evaluate the changes in GLS stratified by CFVR during one year of follow-up in patients with diabetes compared to non-diabetic subjects	baseline, 12 months
Secondary	Correlation between biomarkers and GLS stratified by CFVR	To evaluate the correlation between biomarkers (C-Reactive Protein, Troponin T, NT-proBNP and Uric Acid) and GLS stratified by CFVR in diabetic patients compared to non-diabetic subjects	12 months
Secondary	Correlation between biomarkers and GLS stratified by CAC	To evaluate the correlation between biomarkers (C-Reactive Protein, Troponin T, NT-proBNP and Uric Acid) and GLS stratified by CAC in diabetic patients compared to non-diabetic subjects	12 months
Secondary	Changes in LV function stratified by CAC	To evaluate LV systolic and diastolic function stratified by CAC in patients with diabetes compared to non-diabetic subjects.	baseline, 12 months
Secondary	Changes in LV function stratified by CFVR	To evaluate LV systolic and diastolic function stratified by CFVR in patients with diabetes compared to non-diabetic subjects.	baseline, 12 months
Secondary	Changes in LV function stratified by micro- and macrovascular diabetic status	To evaluate changes in LV systolic and diastolic function in relation to albuminuria, retinopathy, neuropathy, diabetes duration and CAC.	baseline, 12 months
Secondary	Correlation between CFVR and Free Fractional Reserve -Computed Tomography (FFR-CT)	To evaluate the correlation between CFVR and FFR-CT in a subgroup consisting of diabetic patients and non-diabetic subjects.	baseline
Secondary	Correlation between GLS and FFR-CT	To evaluate the correlation between GLS and non-invasive FFR-CT in a subgroup consisting of diabetic patients and non-diabetic subjects.	baseline
Secondary	Changes in GLS in patients with long-term diabetes and no macrovascular disease	To evaluate the impact of historical varying levels of HbA1c and cholesterols on GLS at baseline in patients with diabetes and no macrovascular disease.	baseline