NCT05181631

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."

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

January 6, 2022

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

September 9, 2021

Last Update Submit

December 20, 2021

Conditions

CardiopathyDiabetesMetabolic Syndrome

Keywords

CardiomyopathyDiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • 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. "

    18 months

Study Arms (1)

Biobanking

EXPERIMENTAL

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 .

Other: Biobanking

Interventions

BiobankingOTHER

"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. "

Biobanking

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patient under guardianship curatorship
  • Patient on AME (aide médicale d'état)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart DiseasesDiabetes MellitusMetabolic SyndromeCardiomyopathiesObesity

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel COSSON

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel COSSON

CONTACT

01 48 95 59 47emmanuel.cosson@aphp.fr

Nacira DARGHAL

CONTACT

01 48 95 74 73nacira.darghal@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

January 6, 2022

Study Start

January 15, 2022

Primary Completion

July 30, 2022

Study Completion

September 14, 2023

Last Updated

January 6, 2022

Record last verified: 2021-08