Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype (METAB-HEART)

"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."

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Metabolic Syndrome; Cardiopathy
• Intervention / Treatment: Other: Biobanking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel COSSON; Phone Number: 01 48 95 59 47; Email: emmanuel.cosson@aphp.fr
• Study Contact Backup: Name: Nacira DARGHAL; Phone Number: 01 48 95 74 73; Email: nacira.darghal@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biobanking; 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; "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. "

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Emmanuel COSSON, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2022
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): September 14, 2023

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Cardiomyopathies
• Other Study ID Numbers: APHP210330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No