Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis (NCT03720210) | Clinical Trial Compass
TerminatedNot Applicable
Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis
Stopped: Very low enrollment
United States1 participantsStarted 2018-11-19
Plain-language summary
Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you tell me why it was stopped early, and what that means for what we actually know about whether radiofrequency ablation is safe or effective for amiodarone-induced thyrotoxicosis?
2Since the trial was measuring Free T4 and Total T3 levels after radiofrequency ablation, do we have any partial results showing whether those hormone levels actually improved in the patients who were treated before the study ended?
3Given that this trial was terminated and didn't reach a full conclusion, are there other completed studies or established treatments I should consider first for amiodarone-induced thyrotoxicosis before we discuss RFA as an option?
4Because amiodarone is often used to control serious heart rhythm problems, how would stopping or continuing amiodarone affect my thyroid condition and my heart while we figure out the best treatment approach?
5Radiofrequency ablation is a procedure with its own risks — given that this trial didn't fully establish the safety profile for this specific use, what are the known risks I should weigh against the potential benefit for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.