Erectile Dysfunction, Left Ventricular Diastolic Dysfunction, Metabolic Syndrome
Conditions
Keywords
Tadalafil, SGLT2 inhibitors, Diastolic function, Echocardiography, Endothelial dysfunction, Cardiovascular risk
Brief 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.
Detailed description
This is a prospective, randomized, allocation-concealed, assessor-blinded, parallel-group clinical trial conducted at the Faculty of Medicine, Kafrelsheikh University. The study investigates the association between erectile dysfunction (ED) and left ventricular diastolic dysfunction (LVDD) in men with metabolic syndrome, and evaluates the effects of different treatment strategies on both conditions. A total of 60 male patients aged 41 to 73 years diagnosed with metabolic syndrome and erectile dysfunction will be enrolled and randomly assigned into three parallel groups (1:1:1). The first group will receive tadalafil 5 mg once daily, the second group will receive an SGLT2 inhibitor (dapagliflozin or empagliflozin 10 mg once daily), and the third group will receive a combination of both treatments. The duration of intervention is 3 months. Randomization will be performed using permuted block randomization, with allocation concealment ensured by an independent sequence holder. Outcome assessors will be blinded to treatment allocation. Baseline and follow-up assessments will include clinical evaluation, metabolic parameters, echocardiographic assessment of left ventricular diastolic function, and evaluation of erectile function using the International Index of Erectile Function (IIEF). The primary outcome is the change in erectile function as assessed by IIEF score after 3 months of treatment. Secondary outcomes include changes in echocardiographic parameters of diastolic function, correlation between erectile function and diastolic dysfunction, and identification of predictors of improvement in erectile function. The study aims to provide insight into the relationship between cardiovascular dysfunction and erectile dysfunction in patients with metabolic syndrome and to determine whether combined therapy offers additional benefits over monotherapy.
Interventions
DRUGTadalafil 5 mg
Tadalafil 5 mg once daily for three months
DRUGSGLT-2 inhibitor
SGLT2 inhibitors 10 mg orally once daily for three months
DRUGTadalafil plus SGLT2 inhibitors
Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a randomized, parallel-group interventional study in which eligible male patients with metabolic syndrome will be allocated into separate treatment arms. Each group will receive a specific intervention (e.g., tadalafil, SGLT2 inhibitors, or combination). Participants will remain in their assigned group throughout the study period without crossover. Outcomes, including erectile function and left ventricular diastolic function assessed by echocardiography, will be compared between groups.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male patients aged ≥18 years * History of sexual activity within the past 6 months * Erectile dysfunction for at least 3 months (defined as IIEF-6 score ≤25) * Diagnosed with metabolic syndrome
Exclusion criteria
* \* Left ventricular systolic dysfunction (EF less than 50%) * Recent myocardial infarction (within 1 month) * Moderate to severe valvular heart disease (stenosis or regurgitation) * Renal failure (eGFR \<20 ml/min) * Major pelvic surgery * Significant central nervous system injury (e.g., spinal cord injury) * Endocrine disorders (hypothyroidism, hypogonadism) * Premature ejaculation * Current balanitis or urogenital infections * History of orthostatic hypotension * Any contraindications to tadalafil or SGLT2 inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in erectile function assessed by the International Index of Erectile Function (IIEF) | Baseline and 3 months | Change in erectile function assessed by the International Index of Erectile Function (IIEF-6). The IIEF-6 is a validated questionnaire with scores ranging from 1 to 30, where higher scores indicate better erectile function. The outcome measure will be the change in IIEF-6 score from baseline to 3 months after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular diastolic function assessed by echocardiographic parameters | Baseline and 3 months | Left ventricular diastolic function will be assessed using specific echocardiographic parameters in accordance with ASE/EACVI guidelines, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg). Each parameter will be measured at baseline and at 3 months, and analyzed individually as components of overall diastolic function to evaluate changes over time. |
| Correlation between changes in IIEF score and echocardiographic parameters | Baseline and 3 months | Correlation between changes in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function) and changes in selected echocardiographic parameters of left ventricular diastolic function, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg). |
| Predictors of change in IIEF score | Baseline and 3 months | Identification of independent predictors of change in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function). Predictors include selected clinical variables (age, years; smoking status, categorical), metabolic parameters (waist circumference, cm; systolic and diastolic blood pressure, mmHg; fasting blood glucose, mg/dL; HDL cholesterol, mg/dL; triglycerides, mg/dL), and specific echocardiographic parameters (E/e' ratio, unitless; isovolumic relaxation time \[IVRT\], ms; deceleration time \[DT\], ms; pulmonary artery systolic pressure \[PASP\], mmHg). |
Countries
Egypt
Contacts
STUDY_CHAIRReda B Bastawisy, MD (Professor)
Faculty of medicine, Kafrelshiekh university
STUDY_CHAIRWael A Haseeb, MD (Assistant professor)
Faculty of medicine, Kafrelshiekh university
STUDY_CHAIRMohamed G Abdelraouf, MD
Faculty of medicine, Kafrelshiekh university
Outcome results
None listed