Clinical trial · Observational

Thyrotropin Over-suppression and Heart

Cardiac Effects of Thyrotropin Over-Suppression With Levothyroxine in Young Women With Differentiated Thyroid Cancer

NCT02645786CI-TRIAL-00020421completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Heart Diseases	—	UNRESOLVED	—
Malignant Neoplasm of Thyroid	Malignant Thyroid Gland Neoplasm	ALIAS	0.90
Thyrotoxicosis on Thyroxine Therapy	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
Case
description
Differentiated thyroid cancer group: who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. 1\) age less than 45 years old when receiving total or near-total thyroidectomy, 2) serum level of TSH\<0.1 mU/L in the intermediate recurrence-risk or TSH\<0.3 mU/L in the low recurrence-risk group13, 14 over 2 years before study entry, 3) receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and 4) no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy.
label
Control
description
Control group As each DTC patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria 1\) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.

Primary outcomes (1)

measure
comparison of cardiac fucntion and structure between groups

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 32 Years
Maximum age: 51 Years

Show eligibility criteria text

Inclusion Criteria:

* thyroid cancer group

  1. age less than 45 years old when receiving total or near-total thyroidectomy,
  2. 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,
  3. receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and
  4. no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy.
* control group

  1. the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2),
  2. within the reference range of serum TSH (0.3-4.6 mU/L),
  3. no history of structural heart disease, arrhythmia, or cardiac symptoms,
  4. no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.

Exclusion Criteria:

* who had arrhythmia in electrography or history of cardiac disease

References

Publications (1)

DERIVEDHong KS, Son JW, Ryu OH, Choi MG, Hong JY, Lee SJ. Cardiac Effects of Thyrotropin Oversuppression with Levothyroxine in Young Women with Differentiated Thyroid Cancer. Int J Endocrinol. 2016;2016:9846790. doi: 10.1155/2016/9846790. Epub 2016 Jun 23. PMID 27418929