Left Ventricular DysfunctionDIABECHONCT02956577
Cardiac Function and Microcirculation: Type 2 DIABetes and ECHOcardiographic Changes Over Time
An observational study of Left Ventricular Dysfunction, run by Svendborg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Left Ventricular Dysfunction
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Mar 2016to 20 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes type 1+2 and non-diabetic subjects from the DANCAVAS trial (NCT00662480)
Who may be able to join
- Ability to give informed consent
- Estimated glomerular filtration rate (eGFR) > 45 ml/min
- NYHA I + II
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Cardiovascular Research Unit, OUH Svendborg Hospital
Svendborg, 5700
About this study
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
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.
Read the 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:
- 12-lead electrocardiogram (ECG)
- Urine- and blood samples.
- Measurements of anthropometric data and vital parameters
- Recording of medical history
- 2D transthoracic echocardiography
- Coronary flow velocity reserve (CFVR) with adenosine infusion.
- Coronary computed tomography angiography (CCTA).
- 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.
- Conditions
- Left Ventricular Dysfunction
- Keywords
- Global Longitudinal Strain (GLS), Coronary Flow Velocity Reserve (CFVR), Cardiac dysfunction, Microcirculation, Coronary Computed Tomography Angiography (CCTA), Type 1 Diabetes, Type 2 Diabetes
- Medical subject headings
- Ventricular Dysfunction, Left, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2 | Patients with type 2 diabetes without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were invited from the Outpatient Clinic of Endocrinology or The Eye Photo Clinic at Odense University Hospital (OUH) Svendborg. Diagnosis of diabetes was classified by trained endocrinologists according to international standards with relevant biochemistry. Historical data on urine- and blood samples as well as micro- and macrovascular diabetic complications have been registered consecutively in patients followed at the outpatient clinic in the regional Funen Diabetes Database (FDDB). Data on historical invasive procedures due to cardiac disease were registered in Western Denmark Heart Registry (WDHR). | |
| T1 | Patients with type 1 diabetes without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were invited from the Outpatient Clinic of Endocrinology or The Eye Photo Clinic at OUH Svendborg. Diagnosis of diabetes was classified by trained endocrinologists according to international standards with relevant biochemistry. Historical data on urine- and blood samples as well as micro- and macrovascular diabetic complications have been registered consecutively in patients followed at the outpatient clinic in the regional FDDB. Data on historical invasive procedures due to cardiac disease were registered in WDHR. | |
| Non-diabetic subjects | Non-diabetic subjects without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were included from The Danish Cardiovascular Screening trial (DANCAVAS). A randomized controlled trial with the primary aim to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for cardiovascular disease in men aged 65-74. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 12 months
Secondary outcomes (9)
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
Measured: baseline, 12 months
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
Measured: 12 months
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
Measured: 12 months
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.
Measured: baseline, 12 months
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.
Measured: baseline, 12 months
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.
Measured: baseline, 12 months
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start16 Mar 2016
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Svendborg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokulan Pararajasingam, Svendborg Hospital
- Investigators
- Kenneth Egstrup, DMSci, Study director, Odense University Hospital (OUH) Svendborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956577
- Sponsor's protocol ID
- OUHSVB001
- Acronym
- DIABECHO
- Status last verified
- Oct 2018
- First submitted
- 30 Oct 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02956577
- Acronym / sponsor ID
- DIABECHO / OUHSVB001
- Conditions
- Left Ventricular Dysfunction
- Keywords
- Global Longitudinal Strain (GLS), Coronary Flow Velocity Reserve (CFVR), Cardiac dysfunction, Microcirculation, Coronary Computed Tomography Angiography (CCTA), Type 1 Diabetes, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Svendborg HospitalUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 12-lead electrocardiogram (ECG)
- Urine- and blood samples.
- Measurements of anthropometric data and vital parameters
- Recording of medical history
- 2D transthoracic echocardiography
- Coronary flow velocity reserve (CFVR) with adenosine infusion.
- Coronary computed tomography angiography (CCTA).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2 | – | –Patients with type 2 diabetes without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were invited from the Outpatient Clinic of Endocrinology or The Eye Photo Clinic at Odense University Hospital (OUH) Svendborg. Diagnosis of diabetes was classified by trained endocrinologists according to international standards with relevant biochemistry. Historical data on urine- and blood samples as well as micro- and macrovascular diabetic complications have been registered consecutively in patients followed at the outpatient clinic in the regional Funen Diabetes Database (FDDB). Data on historical invasive procedures due to cardiac disease were registered in Western Denmark Heart Registry (WDHR). |
| T1 | – | –Patients with type 1 diabetes without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were invited from the Outpatient Clinic of Endocrinology or The Eye Photo Clinic at OUH Svendborg. Diagnosis of diabetes was classified by trained endocrinologists according to international standards with relevant biochemistry. Historical data on urine- and blood samples as well as micro- and macrovascular diabetic complications have been registered consecutively in patients followed at the outpatient clinic in the regional FDDB. Data on historical invasive procedures due to cardiac disease were registered in WDHR. |
| Non-diabetic subjects | – | –Non-diabetic subjects without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were included from The Danish Cardiovascular Screening trial (DANCAVAS). A randomized controlled trial with the primary aim to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for cardiovascular disease in men aged 65-74. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes type 1+2 and non-diabetic subjects from the DANCAVAS trial (NCT00662480)
Key inclusion criteria (3 listed)
- Ability to give informed consent
- Estimated glomerular filtration rate (eGFR) > 45 ml/min
- NYHA I + II
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Changes in GLS stratified by Coronary Flow Velocity Reserve (CFVR) in patients with diabetes during one year of follow-up
Time frame: baseline, 12 months
Correlation between biomarkers and GLS stratified by CFVR
Time frame: 12 months
Correlation between biomarkers and GLS stratified by CAC
Time frame: 12 months
Changes in LV function stratified by CAC
Time frame: baseline, 12 months
Changes in LV function stratified by CFVR
Time frame: baseline, 12 months
Changes in LV function stratified by micro- and macrovascular diabetic status
Time frame: baseline, 12 months
Correlation between CFVR and Free Fractional Reserve -Computed Tomography (FFR-CT)
Time frame: baseline
Correlation between GLS and FFR-CT
Time frame: baseline
Changes in GLS in patients with long-term diabetes and no macrovascular disease
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Egstrup, DMSci study director
Odense University Hospital (OUH) Svendborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Dysfunction, run by Svendborg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.