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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in erectile function assessed by the International Index of Erectile Function (IIEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •* 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
研究组 & 干预措施
Tadalafil Group
Participants received tadalafil 5 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.
干预措施: Tadalafil 5 mg (Drug)
SGLT2 inhibitors group
Participants received SGLT2 inhibitors (dapagliflozin or empagliflozin) 10 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.
干预措施: SGLT-2 inhibitor (Drug)
Combination therapy
Participants received combination therapy with tadalafil 5 mg once daily plus SGLT2 inhibitors 10 mg once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.
干预措施: Tadalafil plus SGLT2 inhibitors (Drug)
结局指标
主要结局
Change in erectile function assessed by the International Index of Erectile Function (IIEF)
时间窗: 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.
次要结局
- Change in left ventricular diastolic function assessed by echocardiographic parameters(Baseline and 3 months)
- Correlation between changes in IIEF score and echocardiographic parameters(Baseline and 3 months)
- Predictors of change in IIEF score(Baseline and 3 months)
研究者
Dr Ahmed Ibrahim Shoghy
Principal Investigator (Cardiology Resident)
Kafrelsheikh University