CLAU Test Results (CLinical Assessment And Endothelin fUnction Assessment After Endothelin Receptor Antagonist) : Randomized Controlled Clinical Trial of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Absolute Claudication Distance (ACD) respect baseline values
研究概览
简要总结
A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind was performed in 30 male patients (50-60 years old) with Intermittent Claudication (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6 months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2 weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks and 125 mg twice daily/eight weeks) or control group.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Arterial hypertension and hypercholesterolemia
- •ABI <0,9
- •Positive claudiometry with a claudication distance between 50 and 500
排除标准
- •surgical patient
- •Previous revascularization procedure in the Member studied
- •Uncontrolled hypertension
- •Cardiac Stress Test unfinished
- •Prior DVT
- •Concomitant severe disease
研究组 & 干预措施
Antiaggregants & Statins & Antihypertensives & Bosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) plus Antiaggregant therapy (AAS 100mg/d or Clopidogrel 75mg/d), Statins and Antihypertensive therapy
干预措施: Bosentan (Drug)
Antiaggregants & Statins & Antihypertensives & Bosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) plus Antiaggregant therapy (AAS 100mg/d or Clopidogrel 75mg/d), Statins and Antihypertensive therapy
干预措施: Antiaggregant therapy (Drug)
Antiaggregants & Statins & Antihypertensives & Bosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) plus Antiaggregant therapy (AAS 100mg/d or Clopidogrel 75mg/d), Statins and Antihypertensive therapy
干预措施: Statins (Drug)
Antiaggregants & Statins & Antihypertensives & Bosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) plus Antiaggregant therapy (AAS 100mg/d or Clopidogrel 75mg/d), Statins and Antihypertensive therapy
干预措施: Antihypertensive therapy (Drug)
Antiaggregants & Statins & Antihypertensives
Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy
干预措施: Antiaggregant therapy (Drug)
Antiaggregants & Statins & Antihypertensives
Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy
干预措施: Statins (Drug)
Antiaggregants & Statins & Antihypertensives
Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy
干预措施: Antihypertensive therapy (Drug)
结局指标
主要结局
Change in Absolute Claudication Distance (ACD) respect baseline values
时间窗: 1 Year
To determine the efficacy of bosentan on the improvement in the absolute claudication distance in the exercise in patients with Intermittent Claudication due Peripheral Arterial Disease. ACD and percentage of change, both for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months
Change in flow-mediated arterial dilation (FMAD) respect baseline values
时间窗: 1 Year
To determine the efficacy of bosentan on the improvement in the overall endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease FMAD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months
次要结局
- Changes in Analytical plasma values at each visit respect baseline values(1 Year)
- Change in the ankle brachial index (ABI) respect baseline values(1 Year)
- Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values(1 Year)
- Occurrence of Adverse events during the study(1 Year)
研究者
Joaquin de Haro, M.D.
Randomized controlled clinical trial of Bosentan in Intermittent Claudication in Peripheral Arterial Disease
Hospital Universitario Getafe