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COMPLETED
NCT07563647
PHASE4

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

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

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.

Official title: A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-05

Completion Date

2026-03-17

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

Tadalafil 5 mg

Tadalafil 5 mg once daily for three months

DRUG

SGLT-2 inhibitor

SGLT2 inhibitors 10 mg orally once daily for three months

DRUG

Tadalafil plus SGLT2 inhibitors

Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months

Locations (1)

Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

Kafr ash Shaykh, Kafrelsheikh Governrate, Egypt