Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype (METAB-HEART)
Primary Purpose
Cardiopathy, Diabetes, Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biobanking
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiopathy focused on measuring Cardiomyopathy, Diabetes, Obesity
Eligibility Criteria
Inclusion Criteria:
- Adults (18 years-old or more)
- At high metabolic risk: diabetes of any type and/or obesity (body mass index ≥ 30 kg/m²)
- Admission in the departement of Diabetology-Obesity-Nutrition, Avicenne Hospital, Bobigny, France
- Patient informed and having signed consent
- Patient affiliated to a social security scheme or entitled
Exclusion Criteria:
- Any know cardiac disease: coronary artery disease, heart failure, cardiomyopathy, pulmonary embolism < 6 months, pulmonary hypertension, rhythm disorders < 6 months
- Blood pressure > 180/110 mmHg
- Severe renal failure as defined by estimated glomerular filtration rate < 30 ml/min
- Age ≥ 80 years
- Previous inclusion in the study
- Patient under guardianship curatorship
- Patient on AME (aide médicale d'état)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biobanking
Arm Description
If the patient consents, two tubes of blood will be collected for biobanking, at the same time as routine tubes will be collected. Samples will be collected by hospital staff and stored following regulatory conditions of conservation in the biological resources center of Avicenne hospital .
Outcomes
Primary Outcome Measures
Echographic cardiomyopathy
Echographic cardiomyopathy defined as:
Reduced left ventricular ejection fraction (LVEF)<50%, and/or
Abnormal diastolic function defined as more than half of positive criteria among: E/e'>14, septal e' velocity<7cm/s or lateral e' velocity<10cm/s, Tricuspid regurgitation (TR) velocity>2.8m/s, indexed left atrial (LA) volume>34ml/m², and/or
Isolated left ventricular hypertrophy defined as LV mass ≥115g/m² in male and ≥95g/m² in female
Reduced contractility as defined by global longitudinal strain (GLS) < 20%, and/or If clinical sign & symptom, resting ECG and biomarkers are normal, then echography will not be carried out and the cardiomyopathy will be considered absent. "
Secondary Outcome Measures
Full Information
NCT ID
NCT05181631
First Posted
September 9, 2021
Last Updated
December 20, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05181631
Brief Title
Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype
Acronym
METAB-HEART
Official Title
Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
September 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
"Little is known about the prevalence, determinants and phenotypes of the cardiomyopathy associated with diabetes and/or metabolic syndrome. The emergence of new therapies (SGLT2 inhibitors) that may mitigate and even prevent the onset of heart failure offers new opportunities.The objective of this protocol is to evaluate the prevalence and phenotypes of cardiomyopathy confirmed by echography in people at high metabolic risk defined as living with diabetes or obesity."
Detailed Description
Heart failure (HF) is a frequent disease with a global prevalence of 2.3% that may culminate up to 10% in the elderly. HF is associated with poor outcomes, namely multiple recurrent hospitalizations and high mortality. It is well known for several decades that diabetes is associated with a high cardiovascular mortality, with most physicians initially focusing on coronary artery disease solely. More recently, the concept of specific diabetic and/or metabolic cardiomyopathy emerged with different phenotypes. Obesity and hypertension are highly prevalent in patients with type 2 diabetes (T2D) and several studies have shown similar "diabetic cardiomyopathies" and "obese cardiomyopathies". Congestive HF was found to be two to three times more frequent in patients with T2D than in those without. Asymptomatic HF is underestimated by lack of systematic screening of these patients which prevent them from benefiting from early therapeutics. To our knowledge, no previous study has been made with systematic screening for HF in obese patients without obvious HF signs. Several tools can be used to examine the possible presence of cardiomyopathy and/or HF. The detection of cardiomyopathy at an early, preclinical stage may be of particular interest. First, studies have demonstrated that HF management is more effective at an early stage, with some drugs being associated with a reverse remodeling. Second, the class of SGLT2 inhibitors has proven to reduce the risk of hospitalization for HF in high-risk patients with diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopathy, Diabetes, Metabolic Syndrome
Keywords
Cardiomyopathy, Diabetes, Obesity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biobanking
Arm Type
Experimental
Arm Description
If the patient consents, two tubes of blood will be collected for biobanking, at the same time as routine tubes will be collected.
Samples will be collected by hospital staff and stored following regulatory conditions of conservation in the biological resources center of Avicenne hospital .
Intervention Type
Other
Intervention Name(s)
Biobanking
Intervention Description
"Collection of blood (One tube of blood 4-5 ml + One EDTA tube of blood 5 ml) will be attempted for each participant at baseline. Availability of these samples will be indicated in the e-CRF.
Samples will be collected by hospital staff and stored following regulatory conditions of conservation in CRB of Hospital Avicenne under the responsibility of Pr Marianne ZIOL. "
Primary Outcome Measure Information:
Title
Echographic cardiomyopathy
Description
Echographic cardiomyopathy defined as:
Reduced left ventricular ejection fraction (LVEF)<50%, and/or
Abnormal diastolic function defined as more than half of positive criteria among: E/e'>14, septal e' velocity<7cm/s or lateral e' velocity<10cm/s, Tricuspid regurgitation (TR) velocity>2.8m/s, indexed left atrial (LA) volume>34ml/m², and/or
Isolated left ventricular hypertrophy defined as LV mass ≥115g/m² in male and ≥95g/m² in female
Reduced contractility as defined by global longitudinal strain (GLS) < 20%, and/or If clinical sign & symptom, resting ECG and biomarkers are normal, then echography will not be carried out and the cardiomyopathy will be considered absent. "
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (18 years-old or more)
At high metabolic risk: diabetes of any type and/or obesity (body mass index ≥ 30 kg/m²)
Admission in the departement of Diabetology-Obesity-Nutrition, Avicenne Hospital, Bobigny, France
Patient informed and having signed consent
Patient affiliated to a social security scheme or entitled
Exclusion Criteria:
Any know cardiac disease: coronary artery disease, heart failure, cardiomyopathy, pulmonary embolism < 6 months, pulmonary hypertension, rhythm disorders < 6 months
Blood pressure > 180/110 mmHg
Severe renal failure as defined by estimated glomerular filtration rate < 30 ml/min
Age ≥ 80 years
Previous inclusion in the study
Patient under guardianship curatorship
Patient on AME (aide médicale d'état)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel COSSON
Phone
01 48 95 59 47
Email
emmanuel.cosson@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nacira DARGHAL
Phone
01 48 95 74 73
Email
nacira.darghal@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel COSSON
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype
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