Study of the association between erectile dysfunction and diastolic dysfunction, and the effect of different treatments in men with metabolic syndrome

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202604903325533

Enrollment

Registered

2026-04-23

Start date

2025-05-01

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine Urological and Genital Diseases Cardiology

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male patient aged 18 years or older Sexual relationship within the past 6 months and complaining of ED for at least 3 months (Erectile dysfunction defined as IIEF-6 score = 25) Patients diagnosed with metabolic syndrome

Exclusion criteria

Exclusion criteria: LV systolic dysfunction (EF less than 50%) Recent myocardial infarction (Within 1 month). Moderate to severe valvular lesion (stenosis or regurge). Renal Failure (eGFR less than 20 ml/min) Major pelvic surgery Significant CNS injury Spinal cord injuries Patients with hypothyroidism, hypogonadism, premature ejaculation. Current balanitis and urogenital infections History of orthostatic hypotension and other contraindications reported in the tadalafil and SGLT2i technical data sheets.

Design outcomes

Primary

Measure	Time frame
Change in erectile function as assessed by the International Index of Erectile Function	—

Secondary

Measure	Time frame
Change in left ventricular diastolic function assessed by echocardiographic parameters;Correlation between changes in IIEF score and Echocardiographic parameters ;Predictors of delta change in IIEF score	—

Countries

Egypt

Contacts

Public ContactAhmed Shoghy

Cardiology Resident at Kafrelsheikh University Hospital at Kafrelsheikh University

Ahmed.med_0601@med.kfs.edu.eg201062848476

Outcome results