Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

Atrial Fibrillation Clinical Trial

— ATACA  

Official title:

Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313443
• Other study ID #: ATACA-URT04/06
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2006
• Last updated: July 6, 2011
• Start date: April 2006
• Est. completion date: October 2007

Study information

• Verified date: June 2009
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Atrial Flutter

Intervention

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

Locations

Country	Name	City	State
France	Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Lariboisière	Unité de Recherches Therapeutiques - H. Lariboisiere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.	Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.	One single measure	No
Primary	Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.	Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.	One single measure, taken just before daily administration	No
Primary	Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.	Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.	Cumulated time on amiodarone (varies in each patient)	No
Secondary	Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations	Number of patients having complications (if any) caused by fat tissue needle aspirations	24 hours after needle aspiration	Yes
Secondary	Presence of Any Adverse Effect Attributable to Amiodarone.	Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)	Cumulated time on amiodarone (varies in each patient)	Yes