Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?

Hyperthyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00151723
• Other study ID #: SUBstudie
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2005
• Last updated: July 17, 2007
• Start date: April 2004

Study information

• Verified date: September 2005
• Source: Radboud University
• Contact: Elizabeth Hoogendoorn, MD
• Phone: ++31243614599
• Email: e.hoogendoorn[@]endo.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Pregnancy.

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperthyroidism

Intervention

Procedure:
• treatment with 131I

Locations

Country	Name	City	State
Netherlands	Academical Medical Centre Amsterdam	Amsterdam
Netherlands	Martini Ziekenhuis Groningen	Groningen
Netherlands	University Hospital Groningen	Groningen
Netherlands	Radboud University Medical Centre Nijmegen	Nijmegen
Netherlands	Maxima Medisch Centrum	Veldhoven

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Hoogendoorn EH, Wiersinga WM, Prummel MF, den Heijer M, Corstens FH, Hermus AR. [Subclinical hypothyroidism; the start of a clinical trial into the usefulness of treatment with radioactive iodine]. Ned Tijdschr Geneeskd. 2004 May 8;148(19):953-4. Review. Dutch. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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