Concentrations of Amiodarone in Fat Tissue During Chronic Treatment - Full Text View

Sponsor:	Hopital Lariboisière
Collaborator:	Unité de Recherches Therapeutiques - H. Lariboisiere
Information provided by:	Hopital Lariboisière
ClinicalTrials.gov Identifier:	NCT00313443

Purpose

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.

Condition	Intervention	Phase
Arrhythmia Atrial Fibrillation Atrial Flutter	Procedure: Fat tissue needle aspiration	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:

Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. [ Time Frame: One single measure ] [ Designated as safety issue: No ]
Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.
Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma. [ Time Frame: One single measure, taken just before daily administration ] [ Designated as safety issue: No ]
Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.
Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects. [ Time Frame: Cumulated time on amiodarone (varies in each patient) ] [ Designated as safety issue: No ]
Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.

Secondary Outcome Measures:

Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations [ Time Frame: 24 hours after needle aspiration ] [ Designated as safety issue: Yes ]
Number of patients having complications (if any) caused by fat tissue needle aspirations
Presence of Any Adverse Effect Attributable to Amiodarone. [ Time Frame: Cumulated time on amiodarone (varies in each patient) ] [ Designated as safety issue: Yes ]
Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)

Enrollment:	30
Study Start Date:	April 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Procedure: Fat tissue needle aspiration Small fat tissue sampling performed by needle aspiration. Other Name: Adipose subcutaneous tissue biopsy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313443

Locations

France
Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services
Paris, France, 75010

Sponsors and Collaborators

Hopital Lariboisière

Unité de Recherches Therapeutiques - H. Lariboisiere

Investigators

Principal Investigator:	Carmelo Lafuente-Lafuente, MD	Hopital Lariboisière, Internal Medicine "A" Service, Paris
Study Director:	Jean-Francois Bergmann, MD	Hopital Lariboisiere, Internal Medicine "A" Service, Paris

More Information

No publications provided

Responsible Party:	Dr Carmelo Lafuente-Lafuente, Unité de Recherches Therapeutiques. Hopital Lariboisiere.
ClinicalTrials.gov Identifier:	NCT00313443 History of Changes
Other Study ID Numbers:	ATACA-URT04/06
Study First Received:	April 10, 2006
Results First Received:	June 18, 2009
Last Updated:	July 6, 2011
Health Authority:	France: Ministry of Health

Keywords provided by Hopital Lariboisière:

Anti-Arrhythmia Agents
Amiodarone, chronic treatment
Amiodarone, adverse effects

Biopsy, Fine-Needle, Adipose tissue
Drug concentrations in tissues
Drug accumulation in tissues

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Atrial Fibrillation
Atrial Flutter
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone

Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012