Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.
研究概览
简要总结
The objective of this study is to determine if concentrations of amiodarone in fat tissue increases constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations in fat tissue or not. This is because excessive concentrations of this drug in tissues can produce adverse effects.
详细描述
Amiodarone is very effective to treat cardiac arrhythmias but its use is limited by its toxicity, specially in chronic treatment. Accumulation of the drug in tissues is very probably the cause of the majority of amiodarone delayed adverse effects. However, this has not been proved because obtaining tissue samples is usually difficult and aggressive.
The investigators study, in patients following chronic treatment with amiodarone, if needle aspiration can provide samples of fat tissue useful to accurately determine amiodarone concentrations, how those concentrations in fat tissue correlate with cumulated dose, and how concentrations in fat tissue correlate with concentrations in blood, which is easier to obtain.
The investigators expect this knowledge will help to understand how amiodarone develops its adverse effects and possibly lead to new ways of monitoring treatment with this drug, or to adapt doses in chronic administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients taking amiodarone for more than 3 months (any dose, any indication)
排除标准
- •Impossibility to perform needle aspiration of abdominal wall (local infection, skin disease)
- •Coagulation disorders, INR > 3.0 if warfarin treatment
- •Patient unable to give informed consent
结局指标
主要结局
Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.
时间窗: One single measure
Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.
Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.
时间窗: One single measure, taken just before daily administration
Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.
Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.
时间窗: Cumulated time on amiodarone (varies in each patient)
Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.
次要结局
- Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations(24 hours after needle aspiration)
- Presence of Any Adverse Effect Attributable to Amiodarone.(Cumulated time on amiodarone (varies in each patient))