Thyroid DiseasesNCT03984006
Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins
An observational study of Thyroid Diseases and Heart Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thyroid Diseases, Heart Failure
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2019to 14 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
Who cannot join
- Unclearly diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins.
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.
Read more
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.
- Conditions
- Thyroid Diseases, Heart Failure
- Keywords
- Exosome, Urine, Biological marker
- Medical subject headings
- Thyroid Diseases, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum thyroglobulin level
Comparison to enrollment or between 2 groups
Measured: Within 12 months
Change of serum free T4 level
Comparison to enrollment or between 2 groups
Measured: Within 12 months
Change of serum TSH level
Comparison to enrollment or between 2 groups
Measured: Within 12 months
Change of anti-thyroglobulin level
Comparison to enrollment or between 2 groups
Measured: Within 12 months
Urinary exosomal NT-proBNP detection
Comparison to enrollment or between 2 groups
Measured: Within 12 months
2-D Cardiac Doppler ultrasonography evaluation
Comparison to enrollment or between 2 groups
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start28 Jun 2019
- Primary completion31 Aug 2020
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIH-YUAN WANG, Doctor, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984006
- Sponsor's protocol ID
- 201904095RIND
- Status last verified
- Sep 2021
- First submitted
- 4 Jun 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal Proteins.
- ClinicalTrials.gov ID
- NCT03984006
- Acronym / sponsor ID
- 201904095RIND
- Conditions
- Thyroid Diseases, Heart Failure
- Keywords
- Exosome, Urine, Biological marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
Key exclusion criteria (1 listed)
- Unclearly diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHIH-YUAN WANG, Doctor principal investigator
Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases and Heart Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum thyroglobulin level (time frame: Within 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.