Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins

NCT03984006 | Completed

• 1 other identifier: 201904095RIND
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases; Heart Failure

Keywords

Exosome; Urine; Biological marker

Outcome Measures

Primary Outcomes (6)

• Change of serum thyroglobulin level

  Comparison to enrollment or between 2 groups

  Within 12 months

• Change of serum free T4 level

  Comparison to enrollment or between 2 groups

  Within 12 months

• Change of serum TSH level

  Comparison to enrollment or between 2 groups

  Within 12 months

• Change of anti-thyroglobulin level

  Comparison to enrollment or between 2 groups

  Within 12 months

• Urinary exosomal NT-proBNP detection

  Comparison to enrollment or between 2 groups

  Within 12 months

• 2-D Cardiac Doppler ultrasonography evaluation

  Comparison to enrollment or between 2 groups

  Within 12 months

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Thyroid Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• CHIH-YUAN WANG, Doctor

  Department of Internal Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 12, 2019
• Study Start: June 28, 2019
• Primary Completion: August 31, 2020
• Study Completion: May 14, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)