Official Title: “Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment”

The objective of this study is to determine if concentrations of amiodarone in fat tissue increase 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.

Study Type: Interventional

Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: October 2007

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.

Intervention(s) in this Clinical Trial

• Procedure: Fat tissue needle aspiration
  • Small fat tissue sampling performed by needle aspiration.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings

Primary Measures

• Amiodarone concentration in fat tissue from several sampling points.
  • Time Frame: One single measure
    Safety Issue?: No
• Amiodarone concentration in blood.
  • Time Frame: One single measure, taken just before daily administration
    Safety Issue?: No
• Total cumulated dose of amiodarone and cumulated time of treatment.
  • Time Frame: Cumulated time on amiodarone (varies in each patient)
    Safety Issue?: No

Secondary Measures

• Pain and complications (if any) caused by fat tissue needle aspirations
  • Time Frame: 24 hours after needle aspiration
    Safety Issue?: Yes
• Presence of any adverse effect attributable to amiodarone.
  • Time Frame: Cumulated time on amiodarone (varies in each patient)
    Safety Issue?: Yes

Inclusion Criteria:

• Adult patients taking amiodarone for more than 3 months (any dose, any indication)

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hopital Lariboisière

Overall Clinical Trial Officials and Contacts

Carmelo Lafuente-Lafuente, MD Principal Investigator Hopital Lariboisière, Internal Medicine "A" Service, Paris  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00313443

Study ID Number: ATACA-URT04/06

ClinicalTrials.gov Identifier: NCT00313443

Health Authority: France: Ministry of Health