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CompletedNCT03984006Updated Sep 2, 2021

Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins

An observational study in Thyroid Diseases and Heart Failure, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid Diseases
  • Heart Failure

Keywords

  • Exosome
  • Urine
  • Biological marker
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 5 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unclearly diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change of serum thyroglobulin level

    Comparison to enrollment or between 2 groups

    Time frame: Within 12 months

  2. Change of serum free T4 level

    Comparison to enrollment or between 2 groups

    Time frame: Within 12 months

  3. Change of serum TSH level

    Comparison to enrollment or between 2 groups

    Time frame: Within 12 months

  4. Change of anti-thyroglobulin level

    Comparison to enrollment or between 2 groups

    Time frame: Within 12 months

  5. Urinary exosomal NT-proBNP detection

    Comparison to enrollment or between 2 groups

    Time frame: Within 12 months

  6. 2-D Cardiac Doppler ultrasonography evaluation

    Comparison to enrollment or between 2 groups

    Time frame: Within 12 months

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03984006
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 12, 2019
Start date
Jun 28, 2019
Primary completion
Aug 31, 2020
Completion
May 14, 2021
Last update
Sep 2, 2021

Study contacts

CHIH-YUAN WANG, Doctor
principal investigator · Department of Internal Medicine, National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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