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出境医 / 临床实验 / Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins

Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins

Study Description
Brief Summary:

Autoimmune thyroid disease revealed close relationship with heart failure, including the entities of subclinical hyperthyroidism and hypothyroidism. Heart failure is a principal complication of all forms of heart disease. The American College of Cardiology defines HF as a complex clinical syndrome that impairs the ability of the ventricle to fill with or inject blood. In fact, it may be caused by a defect in myocardial contraction, by an impairment in ventricular filling with preserved systolic function ('diastolic HF') or by a combination of both. Earlier detection of probable trend of heart failure in subclinical thyroid diseases is very important in not only Taiwan, Pan-Asia, but all over the aging world. However, it is not currently available.

The investigators will enroll 20 patients with subclinical hyperthyroidism, subclinical hypothyroidism, and collect their urine specimens in outpatient clinic per year.

Prognostic biological markers via this prospective study. The study was designed as prospective pattern, and the investigators will enroll clinical and subclinical thyroid disease with quarterly follow-up, then detect urine exosomal proteins NT-proBNP. The investigators try to find the correlation of outcome with unknown/fresh biomarkers in this study with time-dependent manner.

The investigators hope to find earlier predicting biomarkers for heart dysfunction in autoimmune thyroid disease.


Condition or disease
Thyroid Diseases Heart Failure

Detailed Description:
Clinical and subclinical thyroid disease is usually used to describe patients with mild symptoms correlated to hyperthyroid or hypothyroid state. Thyroid ultrasonography could differentiate benign or malignant nodular lesion, together with fine needle aspiration cytology and surgical pathology. Thyrotropin (TSH, thyroid stimulating hormone) is the pivotal investigation in laboratory diagnosis to define subclinical thyroid diseases. An elevated TSH with normal free thyroxine and triiodothyronine levels in serum is defined to be subclinical hypothyroidism, and a subnormal TSH with normal thyroid hormone concentrations to be subclinical hyperthyroidism. Generally, the prevalence of subclinical hypothyroidism and hyperthyroidism were reported as 4% -10% & 1%-2% in general population, respectively. Although subclinical thyroid disease is prevalent, there is still no consensus for screening clinical and subclinical thyroid disease, including hyperthyroidism, hypothyroidism, nodular goiter and thyroid cancer. Under consideration of age, gender or familial history of autoimmune thyroid disease. However, screening for thyroid dysfunction should be considered in some high risk patients, including 1) elderly; 2) history of atrial fibrillation; 3) previous thyroid disease history; 4) other confirmed autoimmune diseases; 5) neck exposure of radiation (for example, nasopharyngeal cancer, post-radiation); 6) family history of probable autoimmune thyroid disease, and 7) pregnant state with prior thyroid disease history. Therapeutic decision for clinical and subclinical thyroid dysfunction should be considered individually. Therapeutic options will be anti-thyroid medications and/or radioactive iodine, and thyroidectomy could be considered with larger goiters for hyperthyroidism. For clinical and subclinical hypothyroidism, the therapeutic consideration should be aimed on reduction of progression to overt hypothyroidism, improving heart function, correction of dyslipidemia, and relieving senescence depressive mood. Thyroid ultrasonography will help us to keep long term observation of thyroid structural change. But long term outcome for treatment of such functional and structural thyroid diseases had not been recorded delicately in Taiwan. Further investigations should be observed in the future. The investigators hope to check the relationship between various thyroid diseases and biochemical survey/ultrasonography. The purpose of this study is aiming for early prevention and detection the potential risk factors for thyroid diseases in Taiwan.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins.
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : May 14, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Change of serum thyroglobulin level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups

  2. Change of serum free T4 level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups

  3. Change of serum TSH level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups

  4. Change of anti-thyroglobulin level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups

  5. Urinary exosomal NT-proBNP detection [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups

  6. 2-D Cardiac Doppler ultrasonography evaluation [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The investigators will enroll 20 patients with subclinical hyperthyroidism, subclinical hypothyroidism, and collect their urine specimens in outpatient clinic per year.

The investigators will analyze the urine exosomal proteins and probable biological markers, including NT-proBNP and other proteins.

The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic and follow-up pathway for such patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism).

Criteria

Inclusion Criteria:

  • diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)

Exclusion Criteria:

  • Unclearly diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: CHIH-YUAN WANG, Doctor +886-2-23123456 ext 65371 cyw1965@gmail.com
Contact: LI-TING HUANG, Bachelor +886-2-23123456 ext 65371 pylaff1920@gmail.com

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Chih-Yuan Wang, Doctor    +886-2-23123456 ext 65371    cyw1965@gmail.com   
Contact: Li-Ting Huang, Bachelor    +886-963571218    pylaff1920@gmail.com   
Principal Investigator: Chih-Yuan Wang, Doctor         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: CHIH-YUAN WANG, Doctor Department of Internal Medicine, National Taiwan University Hospital
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 12, 2019
Last Update Posted Date August 10, 2020
Actual Study Start Date June 28, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019)
  • Change of serum thyroglobulin level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups
  • Change of serum free T4 level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups
  • Change of serum TSH level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups
  • Change of anti-thyroglobulin level [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups
  • Urinary exosomal NT-proBNP detection [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups
  • 2-D Cardiac Doppler ultrasonography evaluation [ Time Frame: Within 12 months ]
    Comparison to enrollment or between 2 groups
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins
Official Title Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins.
Brief Summary

Autoimmune thyroid disease revealed close relationship with heart failure, including the entities of subclinical hyperthyroidism and hypothyroidism. Heart failure is a principal complication of all forms of heart disease. The American College of Cardiology defines HF as a complex clinical syndrome that impairs the ability of the ventricle to fill with or inject blood. In fact, it may be caused by a defect in myocardial contraction, by an impairment in ventricular filling with preserved systolic function ('diastolic HF') or by a combination of both. Earlier detection of probable trend of heart failure in subclinical thyroid diseases is very important in not only Taiwan, Pan-Asia, but all over the aging world. However, it is not currently available.

The investigators will enroll 20 patients with subclinical hyperthyroidism, subclinical hypothyroidism, and collect their urine specimens in outpatient clinic per year.

Prognostic biological markers via this prospective study. The study was designed as prospective pattern, and the investigators will enroll clinical and subclinical thyroid disease with quarterly follow-up, then detect urine exosomal proteins NT-proBNP. The investigators try to find the correlation of outcome with unknown/fresh biomarkers in this study with time-dependent manner.

The investigators hope to find earlier predicting biomarkers for heart dysfunction in autoimmune thyroid disease.
Detailed Description Clinical and subclinical thyroid disease is usually used to describe patients with mild symptoms correlated to hyperthyroid or hypothyroid state. Thyroid ultrasonography could differentiate benign or malignant nodular lesion, together with fine needle aspiration cytology and surgical pathology. Thyrotropin (TSH, thyroid stimulating hormone) is the pivotal investigation in laboratory diagnosis to define subclinical thyroid diseases. An elevated TSH with normal free thyroxine and triiodothyronine levels in serum is defined to be subclinical hypothyroidism, and a subnormal TSH with normal thyroid hormone concentrations to be subclinical hyperthyroidism. Generally, the prevalence of subclinical hypothyroidism and hyperthyroidism were reported as 4% -10% & 1%-2% in general population, respectively. Although subclinical thyroid disease is prevalent, there is still no consensus for screening clinical and subclinical thyroid disease, including hyperthyroidism, hypothyroidism, nodular goiter and thyroid cancer. Under consideration of age, gender or familial history of autoimmune thyroid disease. However, screening for thyroid dysfunction should be considered in some high risk patients, including 1) elderly; 2) history of atrial fibrillation; 3) previous thyroid disease history; 4) other confirmed autoimmune diseases; 5) neck exposure of radiation (for example, nasopharyngeal cancer, post-radiation); 6) family history of probable autoimmune thyroid disease, and 7) pregnant state with prior thyroid disease history. Therapeutic decision for clinical and subclinical thyroid dysfunction should be considered individually. Therapeutic options will be anti-thyroid medications and/or radioactive iodine, and thyroidectomy could be considered with larger goiters for hyperthyroidism. For clinical and subclinical hypothyroidism, the therapeutic consideration should be aimed on reduction of progression to overt hypothyroidism, improving heart function, correction of dyslipidemia, and relieving senescence depressive mood. Thyroid ultrasonography will help us to keep long term observation of thyroid structural change. But long term outcome for treatment of such functional and structural thyroid diseases had not been recorded delicately in Taiwan. Further investigations should be observed in the future. The investigators hope to check the relationship between various thyroid diseases and biochemical survey/ultrasonography. The purpose of this study is aiming for early prevention and detection the potential risk factors for thyroid diseases in Taiwan.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

The investigators will enroll 20 patients with subclinical hyperthyroidism, subclinical hypothyroidism, and collect their urine specimens in outpatient clinic per year.

The investigators will analyze the urine exosomal proteins and probable biological markers, including NT-proBNP and other proteins.

The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic and follow-up pathway for such patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism).
Condition
  • Thyroid Diseases
  • Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2019) 		20
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 14, 2021
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)

Exclusion Criteria:

  • Unclearly diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: CHIH-YUAN WANG, Doctor +886-2-23123456 ext 65371 cyw1965@gmail.com
Contact: LI-TING HUANG, Bachelor +886-2-23123456 ext 65371 pylaff1920@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03984006
Other Study ID Numbers 201904095RIND
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: CHIH-YUAN WANG, Doctor Department of Internal Medicine, National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date August 2020

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