NCT00151723

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

July 18, 2007

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

July 17, 2007

Conditions

Hyperthyroidism

Keywords

endogenous subclinical hyperthyroidism

Outcome Measures

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

Interventions

treatment with 131IPROCEDURE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Academical Medical Centre Amsterdam

Amsterdam, Netherlands

RECRUITING

Martini Ziekenhuis Groningen

Groningen, Netherlands

RECRUITING

University Hospital Groningen

Groningen, Netherlands

RECRUITING

Radboud University Medical Centre Nijmegen

Nijmegen, 6500HB, Netherlands

RECRUITING

Maxima Medisch Centrum

Veldhoven, Netherlands

RECRUITING

Related 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. Dutch.

    PMID: 15160563BACKGROUND

MeSH Terms

Conditions

Hyperthyroidism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Ad Hermus, MD, Prof

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Hoogendoorn, MD

CONTACT

++31243614599e.hoogendoorn@endo.umcn.nl

Ad Hermus, MD, Prof

CONTACT

++31243614599

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

April 1, 2004

Last Updated

July 18, 2007

Record last verified: 2005-09

Locations

NL(5)