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Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins

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ClinicalTrials.gov Identifier: NCT03984006
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

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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 : May 28, 2020
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984006


Contacts
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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
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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
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Principal Investigator: CHIH-YUAN WANG, Doctor Department of Internal Medicine, National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03984006     History of Changes
Other Study ID Numbers: 201904095RIND
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Exosome
Urine
Biological marker

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Thyroid Diseases
Cardiovascular Diseases
Endocrine System Diseases