Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype

Not Applicable

• Conditions: Cardiopathy; Diabetes; Metabolic Syndrome
• Interventions: Other: Biobanking

• Registration Number: NCT05181631
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Study Start: 2022-01-15
• Primary Completion: 2022-07-30
• Study Completion: 2023-09-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biobanking	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 .

Primary Outcome Measures

Name	Time	Method
Echographic cardiomyopathy	18 months	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. "