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

UMCN st Radboud
Dept Endocrinologie, huispost 531
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone +31 (0)24 3614599
Email E.Hoogendoorn@ENDO.umcn.nl

Study information

Study designMulticentre randomised single blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymSUBstudy / SUBstudie
Study objectivesTo 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) studiedThyrotoxic symptoms, nodular goiter, hyperthyroidism
InterventionRandomised clinical trial comparing active treatment with 131I with no treatment in subjects with endogenous subclinical hyperthyroidism in a multicenter study.
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/06/2003
Completion date01/06/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants192
Key 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
Key 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 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 enrolment01/06/2003
Date of final enrolment01/06/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

UMCN st Radboud
Nijmegen
6500 HB
Netherlands

Sponsor information

University Medical Centre St Radboud (Netherlands)
Hospital/treatment centre

Centraal Geert Groteplein 10
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone +31 (0)24 3619166
Email PIPmail@po.umcn.nl
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan