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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00151723
First received: September 8, 2005
Last updated: July 17, 2007
Last verified: September 2005
  Purpose

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.


Condition Intervention
Hyperthyroidism
Procedure: treatment with 131I

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Subclinical Hyperthyroidism ”To Treat or Not to Treat?” A Dutch Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: April 2004
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151723

Contacts
Contact: Elizabeth Hoogendoorn, MD ++31243614599 e.hoogendoorn@endo.umcn.nl
Contact: Ad Hermus, MD, Prof ++31243614599

Locations
Netherlands
Academical Medical Centre Amsterdam Recruiting
Amsterdam, Netherlands
Contact: W. Wiersinga, MD, Prof         
University Hospital Groningen Recruiting
Groningen, Netherlands
Contact: G. van den Berg, MD, PhD    ++31-5036161616      
Principal Investigator: G. van den Berg, MD, PhD         
Martini Ziekenhuis Groningen Recruiting
Groningen, Netherlands
Contact: K. van Tol, MD, PhD         
Principal Investigator: K. van Tol, MD, PhD         
Radboud University Medical Centre Nijmegen Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Elizabeth Hoogendoorn, MD    ++31-243614599      
Principal Investigator: Elizabeth Hoogendoorn, MD         
Maxima Medisch Centrum Recruiting
Veldhoven, Netherlands
Contact: H. Haak, MD, PhD         
Principal Investigator: H. Haak, MD, PhD         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Ad Hermus, MD, Prof Radboud University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00151723     History of Changes
Other Study ID Numbers: SUBstudie
Study First Received: September 8, 2005
Last Updated: July 17, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
endogenous subclinical hyperthyroidism

Additional relevant MeSH terms:
Atrial Fibrillation
Hyperthyroidism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 14, 2014