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

Primary Purpose

Hyperthyroidism

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
treatment with 131I
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperthyroidism focused on measuring endogenous subclinical hyperthyroidism

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Academical Medical Centre AmsterdamRecruiting
  • Martini Ziekenhuis GroningenRecruiting
  • University Hospital GroningenRecruiting
  • Radboud University Medical Centre NijmegenRecruiting
  • Maxima Medisch CentrumRecruiting

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
July 17, 2007
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00151723
Brief Title
Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?
Official Title
Subclinical Hyperthyroidism "To Treat or Not to Treat?" A Dutch Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism
Keywords
endogenous subclinical hyperthyroidism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
treatment with 131I
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Hoogendoorn, MD
Phone
++31243614599
Email
e.hoogendoorn@endo.umcn.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Ad Hermus, MD, Prof
Phone
++31243614599
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ad Hermus, MD, Prof
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academical Medical Centre Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Wiersinga, MD, Prof
Facility Name
Martini Ziekenhuis Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. van Tol, MD, PhD
First Name & Middle Initial & Last Name & Degree
K. van Tol, MD, PhD
Facility Name
University Hospital Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. van den Berg, MD, PhD
Phone
++31-5036161616
First Name & Middle Initial & Last Name & Degree
G. van den Berg, MD, PhD
Facility Name
Radboud University Medical Centre Nijmegen
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoogendoorn, MD
Phone
++31-243614599
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoogendoorn, MD
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Haak, MD, PhD
First Name & Middle Initial & Last Name & Degree
H. Haak, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15160563
Citation
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.
Results Reference
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Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?

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