NCT00234520已完成不适用
A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 225
- 试验地点
- 33
- 主要终点
- Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
研究概览
简要总结
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of Acromegaly
- •Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
- •Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
- •Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study
排除标准
- •Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
- •Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
- •Patients who have received treatment with a GH antagonist for more than 3 months
- •Patients who have had heart valve replacement therapy
结局指标
主要结局
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
次要结局
- Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
- Risk in each of the 4 valves at 6 & 12 months
- Prevalence of valvular regurgitation at baseline
- Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months
- Risk of significant regurgitation in each valve at 6 & 12 months
研究者
研究点 (33)
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