Trials / Completed
CompletedNCT00313443
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Hopital Lariboisière · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fat tissue needle aspiration | Small fat tissue sampling performed by needle aspiration. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2006-04-12
- Last updated
- 2011-07-14
- Results posted
- 2009-08-06
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00313443. Inclusion in this directory is not an endorsement.