Trial record 1 of 45 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
Information provided by:
First received: September 8, 2005
Last updated: July 17, 2007
Last verified: September 2005
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.
Procedure: treatment with 131I
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||Subclinical Hyperthyroidism ”To Treat or Not to Treat?” A Dutch Multicenter Trial
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:
| Study Start Date:
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00151723
|Academical Medical Centre Amsterdam
|Amsterdam, Netherlands |
|Contact: W. Wiersinga, MD, Prof |
|Martini Ziekenhuis Groningen
|Groningen, Netherlands |
|Contact: K. van Tol, MD, PhD |
|Principal Investigator: K. van Tol, MD, PhD |
|University Hospital Groningen
|Groningen, Netherlands |
|Contact: G. van den Berg, MD, PhD ++31-5036161616 |
|Principal Investigator: G. van den Berg, MD, PhD |
|Radboud University Medical Centre Nijmegen
|Nijmegen, Netherlands, 6500HB |
|Contact: Elizabeth Hoogendoorn, MD ++31-243614599 |
|Principal Investigator: Elizabeth Hoogendoorn, MD |
|Maxima Medisch Centrum
|Veldhoven, Netherlands |
|Contact: H. Haak, MD, PhD |
|Principal Investigator: H. Haak, MD, PhD |
||Ad Hermus, MD, Prof
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2005
||July 17, 2007
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by Radboud University:
endogenous subclinical hyperthyroidism
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Endocrine System Diseases