A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- compare the 12 month change in left ventricular mass
研究概览
简要总结
Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Biopsy proven systemic AL amyloidosis.
- •Cardiac involvement with septum thickness more than 12 mm (without other causes as published by Gertz et al., hypertension or other potential causes of left ventricular hypertrophy)
- •Previously treated with chemotherapy, induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder.
- •GPT and GOT less than 3-times ULN.
- •Life expectancy more than 12 month.
- •Ability of subject to understand character and individual consequences of the clinical trail.
- •Written informed consent.
- •For women with childbearing potential and men, adequate contraception.
排除标准
- •Age less than 18 years.
- •Concomitant multiple myeloma stage 2 and 3 (Salmon and Durie)
- •Concurrent chemotherapy necessary
- •Time to last chemotherapy more than 6 months.
- •Chronic liver disease, Bilirubin over 1,5 mg/dl
- •Not able to visit Amyloidosis Clinic in Heidelberg every 3 months.
- •History of hypersensitivity to the investigational product or to any substance with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- •Participation in other clinical trials or observation period of competing trials, respectively.
- •Pregnant or nursing women.
研究组 & 干预措施
Epigallocatechin-3-gallate (EGCG)
EGCG 400 mg/d p.o. for 3 months; 800 mg/d p.o. for 3 months, 1200 mg/d p.o. for 6 months
干预措施: Epigallocatechin-3-gallate (EGCG) (Drug)
Placebo
capsules
Dose:
400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
compare the 12 month change in left ventricular mass
时间窗: 12 month
The primary analysis to compare the 12 month change in left ventricular mass between the two treatment arms will be performed by a one-sided two-sample t test at a significance level of 0.025.
次要结局
- Organ response in affected organs other than heart(Baseline, 12 Month)
- safety of EGCG(12 month)
- Overall Survival(12 Month)
- Change in Quality of Life(baseline, 12 month)
- change in cardiac biomarkers(Baseline, 12 Month)
- improvement of hematological remission(Baseline, 12 Month)
研究者
Florian Michel
Study Coordinator
University Hospital Heidelberg