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

NCT ID: NCT00151723

Last Updated: 2007-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

Brief 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.

Conditions

Hyperthyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

treatment with 131I

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Ad Hermus, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Academical Medical Centre Amsterdam

Amsterdam, , Netherlands

Site Status: RECRUITING

Martini Ziekenhuis Groningen

Groningen, , Netherlands

Site Status: RECRUITING

University Hospital Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Radboud University Medical Centre Nijmegen

Nijmegen, , Netherlands

Site Status: RECRUITING

Maxima Medisch Centrum

Veldhoven, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Elizabeth Hoogendoorn, MD

Role: CONTACT

e.hoogendoorn@endo.umcn.nl

++31243614599

Ad Hermus, MD, Prof

Role: CONTACT

++31243614599

Facility Contacts

W. Wiersinga, MD, Prof

Role: primary

K. van Tol, MD, PhD

Role: primary

G. van den Berg, MD, PhD

Role: primary

++31-5036161616

Elizabeth Hoogendoorn, MD

Role: primary

++31-243614599

H. Haak, MD, PhD

Role: primary

References

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. Dutch.

Reference Type: BACKGROUND

PMID: 15160563 (View on PubMed)

Other Identifiers

SUBstudie

Identifier Type: -

Identifier Source: org_study_id