Clinical Trial

Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome

Study acronym: METDDED
Completed Phase 4
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Summary
Metabolic syndrome is associated with an increased risk of cardiovascular disease and is commonly accompanied by erectile dysfunction and subclinical cardiac dysfunction. Erectile dysfunction and left ventricular diastolic dysfunction may share common underlying mechanisms, including endothelial dysfunction and microvascular impairment. This study aims to investigate the association between erectile dysfunction and left ventricular diastolic dysfunction in men with metabolic syndrome, and to evaluate the effects of different treatment strategies, including tadalafil and SGLT2 inhibitors, on both erectile function and cardiac diastolic function. Participants will be randomly assigned to receive tadalafil, an SGLT2 inhibitor, or a combination of both for a duration of three months. Clinical, echocardiographic, and functional assessments will be performed at baseline and after treatment. The results of this study may improve understanding of the link between cardiovascular and sexual dysfunction and help guide therapeutic approaches in this patient population.
Trial Details
NCT Number NCT07563647
Lead Sponsor Kafrelsheikh University
Conditions Erectile Dysfunction, Left Ventricular Diastolic Dysfunction, Metabolic Syndrome
Enrollment 60 participants
Start Date 2025-05-05
Primary Completion 2026-03-17 (estimated)
Study Completion 2026-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-05-04