NCT00527995已完成3 期
Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients
Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
研究概览
简要总结
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age 35-70
- •type 2 diabetes mellitus
- •impotence
- •with and without hypertension, hypercholesteremia
排除标准
- •patients with history of cardiovascular and malignant disease,
- •advanced nephropathy (creatinine≥2.2mg/dl)
- •hepatopathy (liver enzymes higher than the double of normal values)
- •patients taking nitrates
- •CHF: NYHA > II
- •Stable angina: CCS > II
结局指标
主要结局
Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
时间窗: 60 minutes
次要结局
- Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.(60 minutes)
研究者
研究点 (2)
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