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Subclinical Hyperthyroidism "To Treat or Not to Treat?" A Dutch Multicenter Trial.


- candidate number0
- NTR NumberNTR75
- ISRCTNISRCTN04337637
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR21-jun-2005
- Secondary IDsN/A 
- Public TitleSubclinical Hyperthyroidism "To Treat or Not to Treat?" A Dutch Multicenter Trial.
- Scientific TitleSubclinical Hyperthyroidism "To Treat or Not to Treat?" A Dutch Multicenter Trial.
- ACRONYMSUBstudy / SUBstudie
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedThyrotoxic symptoms, Hyperthyroidism, Nodular goiter
- Inclusion criteria1. 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];
2. 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);
3. Informed consent.
- Exclusion criteria1. 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 BMD);
2. Radioiodine therapy in the past;
3. Iodine-induced subclinical hyperthyroidism;
4. Pituitary or hypothalamic insufficiency;
5. Pregnancy;
6. Age <= 50 years and >80 years;
7. Severe non-thyroidal illness;
8. Drug abuse;
9. Unstable angina pectoris, (history of) atrial fibrillation, (history of) congestive heart failure;
10. (History of) osteoporotic fracture(s);
11. Patients younger than 70 years of age with a bone mineral density T-score <2.5 SD, or older than 70 years of age with a bone mineral density Z-score <1.0 SD;
12. These patients can be randomized but in case it is decided to treat them with antiosteoporotic drugs they cannot be evaluated with respect to changes in BMD;
13. 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 betablokkers are started during follow up;
14. Other symptoms or signs of hyperthyroidism or obstruction of vital structures which in the opinion of the attending physician urge to active treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jun-2003
- planned closingdate1-jun-2010
- Target number of participants192
- InterventionsRandomized clinical trial comparing active treatment with 131I with no treatment in subjects with endogenous subclinical hyperthyroidism in a multicenter study.
- Primary outcome1. Progression to overt hyperthyroidism: TSH, fT4, T3 every year;
2. Changes in (thyrotoxic) symptoms (null-hypothesis: radioiodine does not cause improvement):
2.1 Quality of life short form 36 Health Survey: on T=0, T=2 and T=5 years;
2.2 Modified hyperthyroid symptom scale: on T=0, T=2 and T=5 years;
2.3 In the treatment group on T= 1 year: duration of admission to hospital for administration of I131 (if necessary) and signs or symptoms of iodine induced thyroiditis or Graves like disease following iodine treatment making medical treatment necessary;
3. Cardiac changes (null-hypothesis: radioiodine does not prevent development of atrial fibrillation): 3.1 12-lead ECG: on T=0, T=2 and T=5 years;
3.2 Holter monitoring (24 hour): mean 24-hour heart rate, number of PAC and VES: on T=0, T=2 and T=5 years;
4. Changes in bone mineral density (null-hypothesis: radioiodine does not prevent deterioration of BMD): DEXA (Hologic or Lunar) L1-L4 and (right) femoral neck): on T=0, T=2 and T=5 years.
- Secondary outcome1. Progression to overt hyperthyroidism: TSH, fT4, T3 every year. 2. Changes in (thyrotoxic) symptoms (null-hypothesis: radioiodine does not cause improvement): a. Quality of life short form 36 Health Survey: on T=0, T=2 and T=5 years; b. Modified hyperthyroid symptom scale: on T=0, T=2 and T=5 years; c. In the treatment group on T= 1 year: duration of admission to hospital for administration of I131 (if necessary) and signs or symptoms of iodine induced thyroiditis or Graves like disease following iodine treatment making medical treatment necessary; 3. Cardiac changes (null-hypothesis: radioiodine does not prevent development of atrial fibrillation): a. 12-lead ECG: on T=0, T=2 and T=5 years; b. Holter monitoring (24 hour): mean 24-hour heart rate, number of PAC and VES: on T=0, T=2 and T=5 years. 4. Changes in bone mineral density (null-hypothesis: radioiodine does not prevent deterioration of BMD): DEXA (Hologic or Lunar) L1-L4 and (right) femoral neck): on T=0, T=2 and T=5 years.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. E.H. Hoogendoorn
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.R.M.M. Hermus
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center St. Radboud
- PublicationsN/A
- Brief summaryIn various major hospitals, both academic as well as peripheral medical centers, patients fulfilling the inclusion criteria will be selected. Participants with subclinical hyperthyroidism will be randomised into two groups. The first group will be treated for subclinical hyperthyroidism by 131I. The second group will not undergo treatment. A central randomization procedure (by fax or via website) taking into account sex and age will be performed (12 strata).
- Main changes (audit trail)
- RECORD9-aug-2005 - 8-dec-2006


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