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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiopathy focused on measuring Cardiomyopathy, Diabetes, Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 9, 2021
    Last Updated
    December 20, 2021
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    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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