Diabetic CardiomyopathiesCarDiabNCT04593173
Diabetic Cardiomyopathy
An observational study of Diabetic Cardiomyopathies, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Cardiomyopathies
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 1 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic and hypertensive patients, treated in the Internal Medicine and Diabetology Services of Strasbourg University Hospitals, between 04/15/2015 to 04/30/2019.
Who may be able to join
- Adult patient (≥18 years old)
- Type 2 diabetic and hypertensive subjects, cardiac asymptomatic, without myocardial ischemia documented by Dobutamine stress ultrasound (ESD), having at least 1 additional CV risk factor among: dyslipidemia, active or stopped smoking for less than 3 years, family history (1st degree relationship) of major CV accident before age 60, obliterating arteriopathy of the lower limbs and / or carotid atheroma, or proteinuria.
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Patient who expressed his opposition to participating in the study
- Valvular heart disease (moderate to severe valve disease), hypertrophic or dilated (MVGi> 95 g / m2 in women and MVGi> 115 g / m2 in men), chronic pulmonary;
- History of cardiotoxic chemotherapy;
- Subject under legal protection, under guardianship or under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Physiologie et d'Explorations Fonctionnelles
Strasbourg, Starsbourg, 67091
Samy TALHA, MD, 33 3 69 55 13 68, samy.talha@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients
Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.
- Conditions
- Diabetic Cardiomyopathies
- Keywords
- Diabetes, Cardiomyopathy, Diabetic Cardiomyopathies, Type 2 diabetes, Echocardiography, Left ventricle, strain 2D and 3D
- Medical subject headings
- Diabetic Cardiomyopathies, Diabetes Mellitus, Cardiomyopathies, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients
Measured: The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2021
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic CardiomyopathiesStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593173
- Sponsor's protocol ID
- 7905
- Acronym
- CarDiab
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04593173
- Acronym / sponsor ID
- CarDiab / 7905
- Conditions
- Diabetic Cardiomyopathies
- Keywords
- Diabetes, Cardiomyopathy, Diabetic Cardiomyopathies, Type 2 diabetes, Echocardiography, Left ventricle, strain 2D and 3D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- 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.
Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic and hypertensive patients, treated in the Internal Medicine and Diabetology Services of Strasbourg University Hospitals, between 04/15/2015 to 04/30/2019.
Key inclusion criteria (3 listed)
- Adult patient (≥18 years old)
- Type 2 diabetic and hypertensive subjects, cardiac asymptomatic, without myocardial ischemia documented by Dobutamine stress ultrasound (ESD), having at least 1 additional CV risk factor among: dyslipidemia, active or stopped smoking for less than 3 years, family history (1st degree relationship) of major CV accident before age 60, obliterating arteriopathy of the lower limbs and / or carotid atheroma, or proteinuria.
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (4 listed)
- Patient who expressed his opposition to participating in the study
- Valvular heart disease (moderate to severe valve disease), hypertrophic or dilated (MVGi> 95 g / m2 in women and MVGi> 115 g / m2 in men), chronic pulmonary;
- History of cardiotoxic chemotherapy;
- Subject under legal protection, under guardianship or under guardianship.
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
Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients
Time frame: The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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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.
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 Diabetic Cardiomyopathies, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samy TALHA, MD (33 3 69 55 13 68, samy.talha@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients (time frame: The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]). 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 12 Oct 2021.