Amiodarone-Induced Thyrotoxicosis
Conditions
Keywords
Hyperthyroidism, RFA
Brief summary
Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.
Detailed description
Investigators plan to identify patients with amiodarone-induced thyrotoxicosis (AIT) that failed to respond to medical therapy or have developed side effects from medical therapy or are considered high risk for such therapy. These patients will be offered the option to undergo radiofrequency ablation (RFA) of a portion of the thyroid gland in order to decrease thyroid hormone production and/or to inactive the existing thyroid hormone store before their leakage into the circulation. Investigators will follow these patients to assess their clinical response as well as their thyroid values. The safety of the procedure will also be assessed.
Interventions
DEVICERFA
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label single interventional series
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are adults * Have overt thyrotoxicosis (within 2 weeks prior to enrollment) * Are receiving medical therapy for AIT * Are able to understand the study procedures and to comply with them for the entire length of the study * Have not normalized their thyroid levels after one month of standard therapy or * Have persistent and clinically significant thyrotoxicosis (less than 25% decrease in T4 value or patients requiring hospitalization with Congestive heart failure (CHF), tachyarrhythmias, hemodynamic instability or similar co-morbidities) after 2 weeks of standard therapy where additional medical therapy is deemed unlikely to be beneficial or with high risk of side-effects (e.g. hepatotoxicity of antithyroid medications, agranulocytosis of potassium perchlorate or ATD or fluid retention associated with steroids).
Exclusion criteria
* Pregnancy * Patients with prior neck surgery or neck radiation * Patients with neck anatomy that precludes easy access by RFA to the entirety of thyroid parenchyma * Patients on anticoagulation therapy * Patients with comorbidities deemed too high of a risk for general anesthesia * Treatment with another investigational drug or intervention (within 6 weeks of planned RFA). * Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free T4 Response Post RFA | 3 - 6 months | Thyroid tests |
| Total T3 Response Post RFA | 3 - 6 months | Thyroid tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Related to RFA Procedure | 1 - 2 months | McGill Pain Questionnaire |
| Thyroid-stimulating Hormone (TSH) Response Post RFA | 3 - 6 months | Thyroid tests |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RFA Group RFA
RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | RFA Group |
|---|---|
| Age, Customized Age 31 | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Free T4 Response Post RFA
Thyroid tests
Time frame: 3 - 6 months
Population: The one subject enrolled did not return for follow up. Data not collected or analyzed.
Primary
Total T3 Response Post RFA
Thyroid tests
Time frame: 3 - 6 months
Population: The one subject enrolled did not return for follow up. Data not collected or analyzed.
Secondary
Pain Related to RFA Procedure
McGill Pain Questionnaire
Time frame: 1 - 2 months
Population: The one subject enrolled did not return for follow up. Data not collected or analyzed.
Secondary
Thyroid-stimulating Hormone (TSH) Response Post RFA
Thyroid tests
Time frame: 3 - 6 months
Population: The one subject enrolled did not return for follow up. Data not collected or analyzed.