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.
ID
Bron
Verkorte titel
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Progression to overt hyperthyroidism: TSH, fT4, T3 every year;<br>
2. Changes in (thyrotoxic) symptoms (null-hypothesis: radioiodine does not cause
improvement):<br>
2.1 Quality of life – short form 36 Health Survey: on T=0, T=2 and T=5 years;<br>
2.2 Modified hyperthyroid symptom scale: on T=0, T=2 and T=5 years;<br>
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;<br>
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;<br>
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;<br>
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.
Achtergrond van het onderzoek
In 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).
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Randomized clinical trial comparing active treatment with 131I with no treatment in
subjects with endogenous subclinical hyperthyroidism in a multicenter study.
Publiek
P.O. Box 9101
E.H. Hoogendoorn
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3614599
E.Hoogendoorn@ENDO.umcn.nl
Wetenschappelijk
P.O. Box 9101
E.H. Hoogendoorn
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3614599
E.Hoogendoorn@ENDO.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL52 |
| NTR-old | NTR75 |
| Ander register | : N/A |
| ISRCTN | ISRCTN04337637 |