Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Summary
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.
Description
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.
We 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.
We 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.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Arrhythmia
Intervention
Fat tissue needle aspiration
Location
Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services
Paris
France
75010
Status
Completed
Source
Hopital Lariboisière
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00313443
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Biopsy, Needle
Removal and examination of tissue obtained through a transdermal needle inserted into the specific region, organ, or tissue being analyzed.
Cordocentesis
The collecting of fetal blood samples via ultrasound-guided needle aspiration of the blood in the umbilical vein.
Oocyte Retrieval
Procedures to obtain viable OOCYTES from the host. Oocytes most often are collected by needle aspiration from OVARIAN FOLLICLES before OVULATION.
Needle Sharing
Usage of a single needle among two or more people for injecting drugs. Needle sharing is a high-risk behavior for contracting infectious disease.
Ultrasonography, Interventional
The use of ultrasound to guide minimally invasive surgical procedures such as needle ASPIRATION BIOPSY; DRAINAGE; etc. Its widest application is intravascular ultrasound imaging but it is useful also in urology and intra-abdominal conditions.
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