Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313443
Status:
COMPLETED
Last Update Posted:
2011-07-14
First Post:
2006-04-10
Brief Title:
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Sponsor:
Hopital Lariboisière
Organization:
Hopital Lariboisière
Study Overview
Official Title:
Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATACA
Brief 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
Detailed 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None