Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

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 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.

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.

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: Amiodarone, long-term
  • Unique arm: all patients were taking amiodarone for more than 6 months and all patietns underwent amiodarone dosage in blood and fat tissue samplings

Primary Measures

• Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.
  • Time Frame: One single measure
    Safety Issue?: No
• Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.
  • Time Frame: One single measure, taken just before daily administration
    Safety Issue?: No
• Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.
  • 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 Investigator: Hopital Lariboisière Other

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 February 09, 2012

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