CClinicalTrials.gg
Status unknownNCT00151723Updated Jul 18, 2007

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

An interventional study of treatment with 131I in Hyperthyroidism, sponsored by Radboud University Medical Center. Status unknown at 5 sites in Netherlands. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2007-07-18.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperthyroidism

Browse trials for

Keywords

  • endogenous subclinical hyperthyroidism
03

In context

Hyperthyroidism

111 studies on the registry are indexed under Hyperthyroidism; 28 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 54 interventional studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Interventions

  • Proceduretreatment with 131I
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

5 of 5 sites recruiting
  • Academical Medical Centre Amsterdam
    Amsterdam, Netherlands
    • W. Wiersinga, MD, Prof · Contact
    Recruiting
  • Martini Ziekenhuis Groningen
    Groningen, Netherlands
    • K. van Tol, MD, PhD · Contact
    • K. van Tol, MD, PhD · Principal investigator
    Recruiting
  • University Hospital Groningen
    Groningen, Netherlands
    • G. van den Berg, MD, PhD · Contact · ++31-5036161616
    • G. van den Berg, MD, PhD · Principal investigator
    Recruiting
  • Radboud University Medical Centre Nijmegen
    Nijmegen, 6500HB, Netherlands
    • Elizabeth Hoogendoorn, MD · Contact · ++31-243614599
    • Elizabeth Hoogendoorn, MD · Principal investigator
    Recruiting
  • Maxima Medisch Centrum
    Veldhoven, Netherlands
    • H. Haak, MD, PhD · Contact
    • H. Haak, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 15160563 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00151723
Lead sponsor
Radboud University Medical Center
First posted
Sep 9, 2005
Start date
Apr 2004
Last update
Jul 18, 2007

Study contacts

Elizabeth Hoogendoorn, MD
Contact
e.hoogendoorn@endo.umcn.nl
++31243614599
Ad Hermus, MD, Prof
Contact
++31243614599
Ad Hermus, MD, Prof
principal investigator · Radboud University Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion