Subclinical Hyperthyroidism 'To Treat or Not to Treat?' - A Dutch Multicentre Trial
ISRCTN | ISRCTN04337637 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN04337637 |
Secondary identifying numbers | NTR75 |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 24/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E.H. Hoogendoorn
Scientific
Scientific
UMCN st Radboud
Dept Endocrinologie, huispost 531
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
Phone | +31 (0)24 3614599 |
---|---|
E.Hoogendoorn@ENDO.umcn.nl |
Study information
Study design | Multicentre randomised single blind active controlled parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | SUBstudy / SUBstudie |
Study objectives | 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. |
Ethics approval(s) | Received from local medical ethics committee |
Health condition(s) or problem(s) studied | Thyrotoxic symptoms, nodular goiter, hyperthyroidism |
Intervention | Randomised clinical trial comparing active treatment with 131I with no treatment in subjects with endogenous subclinical hyperthyroidism in a multicenter study. |
Intervention type | Other |
Primary outcome measure | 1. 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 outcome measures | Not provided at time of registration |
Overall study start date | 01/06/2003 |
Completion date | 01/06/2010 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 192 |
Key inclusion criteria | 1. 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 |
Key exclusion criteria | 1. 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 randomised 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 betablockers 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. |
Date of first enrolment | 01/06/2003 |
Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
UMCN st Radboud
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
University Medical Centre St Radboud (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Centraal Geert Groteplein 10
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
Phone | +31 (0)24 3619166 |
---|---|
PIPmail@po.umcn.nl | |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
University Medical Centre St. Radboud (Netherlands)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |