CompletedNot Applicable

Thyrotropin Over-suppression and Heart

31 participantsStarted 2009-09

Plain-language summary

The investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH) over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered during suppression therapy.

Who can participate

Age range

32 Years – 51 Years

Sex

FEMALE

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

. age less than 45 years old when receiving total or near-total thyroidectomy,
. serum level of TSH\<0.1 mU/L in the intermediate -risk or TSH\<0.3 mU/L in the low recurrence-risk group over 2 years before study entry,
. receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and
. no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy.
. the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2),
. within the reference range of serum TSH (0.3-4.6 mU/L),
. no history of structural heart disease, arrhythmia, or cardiac symptoms,
. no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

comparison of cardiac fucntion and structure between groups

Timeframe: measure cardiac function and struture at 2009 in case (DTC group) and at 2010 in control group

Trial details

NCT IDNCT02645786

SponsorChuncheon Sacred Heart Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Malignant Neoplasm of Thyroid trials