Purpose

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.


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

Genetics Home Reference related topics:   Arrhythmia   familial atrial fibrillation  

MedlinePlus related topics:   Arrhythmia  

ChemIDplus related topics:   Amiodarone   Amidox   Amiodarone hydrochloride  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:   Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment

Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • Amiodarone concentration in fat tissue from several sampling points. [ Time Frame: One single measure ] [ Designated as safety issue: No ]
  • Amiodarone concentration in blood. [ Time Frame: One single measure, taken just before daily administration ] [ Designated as safety issue: No ]
  • Total cumulated dose of amiodarone and cumulated time of treatment. [ Time Frame: Cumulated time on amiodarone (varies in each patient) ] [ Designated as safety issue: No ]

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 ]
  • Presence of any adverse effect attributable to amiodarone. [ Time Frame: Cumulated time on amiodarone (varies in each patient) ] [ Designated as safety issue: Yes ]

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
1: Experimental
Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Procedure: Fat tissue needle aspiration
Small fat tissue sampling performed by needle aspiration.

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.

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.

  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    
France
Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services    
      Paris, France, 75010
Hopital Lariboisière
Unité de Recherches Therapeutiques - H. Lariboisiere
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

Responsible Party:   Unité de Recherches Therapeutiques. Hopital Lariboisiere. ( Dr Carmelo Lafuente-Lafuente )
Study ID Numbers:   ATACA-URT04/06
First Received:   April 10, 2006
Last Updated:   January 2, 2008
ClinicalTrials.gov Identifier:   NCT00313443
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

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Amiodarone
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Vasodilator Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Arrhythmias, Cardiac
Pharmacologic Actions

Source: National Library of Medicine (NLM) July 10, 2008

  


 
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