NCT01390181终止不适用
The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Inflammatory Markers Levels
研究概览
简要总结
The specific aims of this study are to:
- Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm.
- Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
- In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >age 18 years and < 65 years old
- •Able to give informed consent
- •Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva >4.0cm
- •No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
- •Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.
排除标准
- •Unable to safely take losartan due to one or more of the following:
- •Hypersensitivity to losartan or other angiotensin receptor blockers
- •Pregnancy
- •Nursing mothers
- •History of angioedema
- •Hypotension - chronically volume depleted patients
- •Hepatic or renal impairment (Cr>1.5mg/dL)
- •Hyperkalemia (K+>4.8)
- •Renal artery stenosis
- •Severe congestive heart failure (class III-IV)
- •Currently taking potassium supplements or salt substitutes containing potassium
- •Currently taking lithium
- •Prior surgical intervention to aorta or aortic valve
- •Unable or unwilling to give informed consent and follow up with study activities
- •Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
- •Females of child bearing who are unwilling to practice adequate birth control throughout the study.
研究组 & 干预措施
Losartan
Experimental
干预措施: Cozaar (Drug)
结局指标
主要结局
Inflammatory Markers Levels
时间窗: Baseline and 12 months
Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), \& Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.
次要结局
未报告次要终点
研究者
Anna Booher
MD
University of Michigan
研究点 (1)
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