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Clinical Trial 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."


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05181631
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Emmanuel COSSON
Phone 01 48 95 59 47
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 15, 2022
Completion date September 14, 2023

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