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NCT03984006

Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins

Completed Last updated 2 September 2021
What this trial tests

trial in Thyroid Diseases in 5 participants. Completed in 14 May 2021.

Timeline
28 June 2019
Primary endpoint
31 August 2020
14 May 2021

Quick facts

Lead sponsorNational Taiwan University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment5
Start date28 June 2019
Primary completion31 August 2020
Estimated completion14 May 2021
Sites1 location across Taiwan

Conditions studied

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 80, any sex, with Thyroid Diseases or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
    Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
  2. Clinical applications for exosomes: Are we there yet?
    Perocheau D, Touramanidou L, Gurung S, Gissen P, et al · · 2021 · cited 101× · PMID 33751579 · DOI 10.1111/bph.15432
  3. The Role of Extracellular Vesicles in the Pathogenesis and Treatment of Autoimmune Disorders.
    Lu M, DiBernardo E, Parks E, Fox H, et al · · 2021 · cited 52× · PMID 33732229 · DOI 10.3389/fimmu.2021.566299
  4. Global requirements for manufacturing and validation of clinical grade extracellular vesicles.
    Thakur A, Rai D. · · 2024 · cited 24× · PMID 40027307 · DOI 10.1016/j.jlb.2024.100278
  5. Exosomes: Biological Pharmaceutical Nanovectors for Theranostics.
    Thomas SC, Kim JW, Pauletti GM, Hassett DJ, et al · · 2021 · cited 18× · PMID 35096795 · DOI 10.3389/fbioe.2021.808614
  6. Exosomal Biomarkers: A Comprehensive Overview of Diagnostic and Prognostic Applications in Malignant and Non-Malignant Disorders.
    Delshad M, Sanaei MJ, Mohammadi MH, Sadeghi A, et al · · 2025 · cited 13× · PMID 40305328 · DOI 10.3390/biom15040587
  7. Role of stem cell derivatives in inflammatory diseases.
    Yang Y, Peng Y, Li Y, Shi T, et al · · 2023 · cited 13× · PMID 37006266 · DOI 10.3389/fimmu.2023.1153901
  8. Unfathomed Nanomessages to the Heart: Translational Implications of Stem Cell-Derived, Progenitor Cell Exosomes in Cardiac Repair and Regeneration.
    Thej C, Kishore R. · · 2021 · cited 8× · PMID 34359980 · DOI 10.3390/cells10071811

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Other recruiting trials for Thyroid Diseases

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