Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

Amiodarone-Induced Thyrotoxicosis Clinical Trial

Official title:

Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03720210
• Other study ID #: 18-004450
• Status: Terminated
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: December 7, 2020

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amiodarone-Induced Thyrotoxicosis
• Thyrotoxicosis

Intervention

Device:
• RFA
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free T4 Response Post RFA	Thyroid tests	3 - 6 months
Primary	Total T3 Response Post RFA	Thyroid tests	3 - 6 months
Secondary	Pain Related to RFA Procedure	McGill Pain Questionnaire	1 - 2 months
Secondary	Thyroid-stimulating Hormone (TSH) Response Post RFA	Thyroid tests	3 - 6 months

External Links

•   Mayo Clinic Clinical Trials