Trial Outcomes & Findings for Concentrations of Amiodarone in Fat Tissue During Chronic Treatment (NCT NCT00313443)

Results Overview

Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

One single measure

Results posted on

2011-07-14

Participant Flow

Recruitment at a teaching hospital, from July 2006 to October 2007.

67 consecutive patients were evaluated and 30 patients included. Reasons for non inclusion were: impossible to retrace history of amiodarone administration: 19 patients; less than 3 months on amiodarone treatment: 10 patients; unable to give informed consent: 4 patients; refused to participate: 4 patients.

Participant milestones

Participant milestones
Measure	Amiodarone/Fat Tissue Needle Aspiration Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 Participants Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age Continuous	75 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment France	30 participants n=5 Participants

PRIMARY outcome

Timeframe: One single measure

Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.

Outcome measures

Outcome measures
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 Participants Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.	0.20 Correlation coefficient R

PRIMARY outcome

Timeframe: One single measure, taken just before daily administration

Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.

Outcome measures

Outcome measures
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 Participants Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.	0.68 Correlation coefficient R

PRIMARY outcome

Timeframe: Cumulated time on amiodarone (varies in each patient)

Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.

Outcome measures

Outcome measures
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 Participants Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.	1.01 Logistic regression OR

SECONDARY outcome

Timeframe: 24 hours after needle aspiration

Number of patients having complications (if any) caused by fat tissue needle aspirations

Outcome measures

Outcome measures
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 Participants Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations	2 Patients

SECONDARY outcome

Timeframe: Cumulated time on amiodarone (varies in each patient)

Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)

Outcome measures

Outcome measures
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 Participants Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Presence of Any Adverse Effect Attributable to Amiodarone.	11 Patients

Adverse Events

Amiodarone/Fat Tissue Needle Aspiration

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Amiodarone/Fat Tissue Needle Aspiration n=30 participants at risk Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
Skin and subcutaneous tissue disorders Local Complications (if Any) Caused by Fat Tissue Needle Aspirations	6.7% 2/30 • Number of events 2

Additional Information

Dr Carmelo Lafuente-Lafuente

Unité de Recherches Thérapeutiques. Service de Médecine Interne A. Hôpital Lariboisière. Paris, France

Phone: +33 1 49 95 63 37

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place