Phase 4
N=30
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Arrhythmia · Atrial Fibrillation · Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT00313443 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: Primary: Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. — 0.20 Correlation coefficient R
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fat tissue needle aspiration (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hopital Lariboisière
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. |
0.20 | — |
| PRIMARY Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma. |
0.68 | — |
| PRIMARY Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects. |
1.01 | — |
| SECONDARY Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations |
2 | — |
| SECONDARY Presence of Any Adverse Effect Attributable to Amiodarone. |
11 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00313443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.