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Trial record 1 of 1 for:    NCT02645786
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Thyrotropin Over-suppression and Heart

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ClinicalTrials.gov Identifier: NCT02645786
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
OHKHYUN RYU, Chuncheon Sacred Heart Hospital

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.

Condition or disease
Malignant Neoplasm of Thyroid Heart Diseases Thyrotoxicosis on Thyroxine Therapy

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cardiac Effects of Thyrotropin Over-Suppression With Levothyroxine in Young Women With Differentiated Thyroid Cancer
Study Start Date : September 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. comparison of cardiac fucntion and structure between groups [ Time Frame: measure cardiac function and struture at 2009 in case (DTC group) and at 2010 in control group ]
    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.


Secondary Outcome Measures :
  1. comparison of heart rate between groups [ Time Frame: measure heart rate at 2009 in case (DTC group) and at 2010 in control group. ]
    In DTC group, the investiagtors measured heart rate 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.Heart rate were evaluated at 2010 in control group.

  2. comparison of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) between groups [ Time Frame: measure NT-pro-BNP at 2009 in DTC group and at 2010 in control group ]
    In DTC group, the investiagtors measured NT-Pro-BNP 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.NT-Pro-BNP was evaluated at 2010 in control group.

  3. thyroid function test (TSH, free T4, free T3) [ Time Frame: comparison of thyroid function at 2009 in case (DTC) and 2010 in control group ]
    In DTC group, the investiagtors measured thyroid function test 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.Thyroid function test was evaluated at 2010 in control group.


Biospecimen Retention:   Samples Without DNA
serum and plasma


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Ages Eligible for Study:   32 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: OHKHYUN RYU, Associate professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02645786    
Other Study ID Numbers: 2009-19
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plan to share the data with other investigator.
Keywords provided by OHKHYUN RYU, Chuncheon Sacred Heart Hospital:
thyroid neoplasms
heart
thyroxine
thyrotoxicosis
Additional relevant MeSH terms:
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Thyroid Neoplasms
Heart Diseases
Thyroid Diseases
Thyrotoxicosis
Neoplasms
Cardiovascular Diseases
Endocrine System Diseases
Hyperthyroidism
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms