Trial record 1 of 30 for:
Open Studies | "Hyperthyroidism"
Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Radboud University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Radboud University
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00151723
First received: September 8, 2005
Last updated: July 17, 2007
Last verified: September 2005
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Purpose
Subclinical hyperthyroidism is defined as the presence of serum free thyroxine (T4) and triiodothyronine (T3) levels within the reference range and a reduced serum thyrotrophin (TSH) level. Evidence is accumulating that it has important clinical effects. The SUBstudy is a randomised, Dutch multicenter trial to study whether radioiodine treatment prevents the development of atrial fibrillation and prevents decreases in bone mineral density in patients with endogenous subclinical hyperthyroidism.
| Condition | Intervention |
|---|---|
|
Hyperthyroidism |
Procedure: treatment with 131I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Subclinical Hyperthyroidism ”To Treat or Not to Treat?” A Dutch Multicenter Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- To provide evidence that restoration of euthyroidism (normal TSH) improves thyrotoxic symptoms and signs and quality of life and lowers the risk of subsequent atrial fibrillation and bone loss in subjects with endogenous subclinical hyperthyroidism
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2004 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subclinical hyperthyroidism [TSH ≤ 0.1 mU/L, fT4 and T3 within the normal range of the own laboratory (determined 2 times in own laboratory) with an interval of at least 2 months].
- Endogenous cause of subclinical hyperthyroidism limited to autonomous adenoma or multinodular goiter (diagnosis made by the attending physician, based on palpation and the result of a thyroid scintigram).
- Informed consent.
Exclusion Criteria:
- Medication with anti-thyroid drugs in the last 3 months (also not allowed during follow-up); thyroid hormone in the last 3 months (allowed during follow-up, but TSH levels should be kept between 0.1 mU/L and the upper limit of normal in the own laboratory); and oral glucocorticoids in the last 3 months (allowed during follow-up when absolutely necessary, but patients in whom glucocorticoids are started cannot be evaluated with respect to changes in bone mineral density [BMD]).
- Radioiodine therapy in the past.
- Iodine-induced subclinical hyperthyroidism.
- Pituitary or hypothalamic insufficiency.
- Pregnancy.
- Age <= 40 years.
- Severe non-thyroidal illness.
- Drug abuse.
- Unstable angina pectoris, (history of) atrial fibrillation, (history of) congestive heart failure.
- (History of) osteoporotic fracture(s).
- Patients younger than 70 years of age with a bone mineral density T-score < – 2.5 standard deviations (SD), or older than 70 years of age with a bone mineral density Z-score < 1.0 SD. (These patients can be randomized but in case it is decided to treat them with anti-osteoporotic drugs they cannot be evaluated with respect to changes in BMD.)
- Use of betablockers in the last three months. (These patients can be randomised but cannot be evaluated with respect to general and cardiac symptoms. The same applies to patients in whom betablockers are started during follow up.)
- Other symptoms or signs of hyperthyroidism or obstruction of vital structures which, in the opinion of the attending physician, require active treatment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151723
Contacts
| Contact: Elizabeth Hoogendoorn, MD | ++31243614599 | e.hoogendoorn@endo.umcn.nl |
| Contact: Ad Hermus, MD, Prof | ++31243614599 |
Locations
| Netherlands | |
| Academical Medical Centre Amsterdam | Recruiting |
| Amsterdam, Netherlands | |
| Contact: W. Wiersinga, MD, Prof | |
| University Hospital Groningen | Recruiting |
| Groningen, Netherlands | |
| Contact: G. van den Berg, MD, PhD ++31-5036161616 | |
| Principal Investigator: G. van den Berg, MD, PhD | |
| Martini Ziekenhuis Groningen | Recruiting |
| Groningen, Netherlands | |
| Contact: K. van Tol, MD, PhD | |
| Principal Investigator: K. van Tol, MD, PhD | |
| Radboud University Medical Centre Nijmegen | Recruiting |
| Nijmegen, Netherlands, 6500HB | |
| Contact: Elizabeth Hoogendoorn, MD ++31-243614599 | |
| Principal Investigator: Elizabeth Hoogendoorn, MD | |
| Maxima Medisch Centrum | Recruiting |
| Veldhoven, Netherlands | |
| Contact: H. Haak, MD, PhD | |
| Principal Investigator: H. Haak, MD, PhD | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | Ad Hermus, MD, Prof | Radboud University Medical Centre |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00151723 History of Changes |
| Other Study ID Numbers: | SUBstudie |
| Study First Received: | September 8, 2005 |
| Last Updated: | July 17, 2007 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
endogenous subclinical hyperthyroidism |
Additional relevant MeSH terms:
|
Atrial Fibrillation Hyperthyroidism Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013