NCT00313443

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 6, 2009

Completed
Last Updated

July 14, 2011

Status Verified

June 1, 2009

Enrollment Period

1.5 years

First QC Date

April 10, 2006

Results QC Date

June 18, 2009

Last Update Submit

July 6, 2011

Conditions

ArrhythmiaAtrial FibrillationAtrial Flutter

Keywords

Anti-Arrhythmia AgentsAmiodarone, chronic treatmentAmiodarone, adverse effectsBiopsy, Fine-Needle, Adipose tissueDrug concentrations in tissuesDrug accumulation in tissues

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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)

Secondary Outcomes (2)

  • Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations

    24 hours after needle aspiration

  • Presence of Any Adverse Effect Attributable to Amiodarone.

    Cumulated time on amiodarone (varies in each patient)

Study Arms (1)

Amiodarone, long-term

EXPERIMENTAL

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

Interventions

Fat tissue needle aspirationPROCEDURE

Small fat tissue sampling performed by needle aspiration.

Also known as: Adipose subcutaneous tissue biopsy
Amiodarone, long-term

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services

Paris, 75010, France

Location

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Small number of patients included. High variability of amiodarone concentrations in fat tissue between the 2 simultaneous samples for some patients. Incidence of amiodarone-related adverse effects probably overestimated.

Results Point of Contact

Title
Dr Carmelo Lafuente-Lafuente
Organization
Unité de Recherches Thérapeutiques. Service de Médecine Interne A. Hôpital Lariboisière. Paris, France
c.lafuente@nodo3.net
+33 1 49 95 63 37

Study Officials

  • Carmelo Lafuente-Lafuente, MD

    Hopital Lariboisière, Internal Medicine "A" Service, Paris

    PRINCIPAL INVESTIGATOR

  • Jean-Francois Bergmann, MD

    Hopital Lariboisiere, Internal Medicine "A" Service, Paris

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

July 14, 2011

Results First Posted

August 6, 2009

Record last verified: 2009-06

Locations

FR(1)