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| Sponsor: | Radboud University |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00151723 |
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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Elizabeth Hoogendoorn, MD | ++31243614599 | e.hoogendoorn@endo.umcn.nl |
| Contact: Ad Hermus, MD, Prof | ++31243614599 |
| 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 | |
| Principal Investigator: | Ad Hermus, MD, Prof | Radboud University Medical Centre |
More Information
| 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) |
|
endogenous subclinical hyperthyroidism |
|
Atrial Fibrillation Hyperthyroidism Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Thyroid Diseases Endocrine System Diseases |