Thyrotropin Over-suppression and Heart

NCT02645786 | Completed

• 1 other identifier: 2009-19
• Study Type: observational
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignant Neoplasm of Thyroid; Heart Diseases; Thyrotoxicosis on Thyroxine Therapy

Keywords

thyroid neoplasms; heart; thyroxine; thyrotoxicosis

Outcome Measures

Primary Outcomes (1)

• comparison of cardiac fucntion and structure between groups

  In DTC group, the investiagtors measured cardiac function and structure by echocardiography at 2009 (receiving TSH suppressive therapy for 5 to 9 years after thyroidectomy). As each DTC patient was enrolled, control subjects were selected from persons 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.The cardiac function and structure were evaluated by echocardiography at 2010.

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

Secondary Outcomes (3)

• comparison of heart rate between groups

  measure heart rate at 2009 in case (DTC group) and at 2010 in control group.

• comparison of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) between groups

  measure NT-pro-BNP at 2009 in DTC group and at 2010 in control group

• thyroid function test (TSH, free T4, free T3)

  comparison of thyroid function at 2009 in case (DTC) and 2010 in control group

Study Arms (2)

Case

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.

Control

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.

Eligibility Criteria

• Age: 32 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

female differentiated thyroid cancer patients who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. Finally, 14 DTC patients were enrolled and studied from September 2009 to March 2010. As each patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. All subjects who met the enrollment criteria took an electrocardiogram to rule out arrhythmias.

You may qualify if:

• thyroid cancer group
• 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.
• control group
• 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.

You may not qualify if:

• who had arrhythmia in electrography or history of cardiac disease

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Related Publications (1)

• Hong 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Thyroid Neoplasms; Heart Diseases; Thyrotoxicosis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Cardiovascular Diseases; Hyperthyroidism

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: January 5, 2016
• Study Start: September 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 5, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share