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ISRCTN
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ISRCTN66874446
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ClinicalTrials.gov identifier
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Public title
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UK Trial of Radioiodine Intervention in Subclinical Hyperthyroidism
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Scientific title
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Acronym
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TRISH
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Serial number at source
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G0500783
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Study hypothesis
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Radioiodine treatment for sustained subclinical hyperthyroidism will not reduce circulatory endpoints in the elderly.
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Ethics approval
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Approval gained from the Newcastle and North Tyneside Research Ethics Committee (reference number: 06/Q0905/112).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Subclinical hyperthyroidism
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Participants - inclusion criteria
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1. Over 65 years of age
2. Sustained subclinical hyperthyroidism (undetectable Thyroid Stimulating Hormome [TSH], normal free thyroid
hormones) for greater than three months
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Participants - exclusion criteria
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1. Patient currently has or has ever had Atrial Fibrillation (AF)
2. Certain drug usage
3. Pituitary, severe renal or hepatic disease
4. Unstable coronary disease
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Anticipated start date
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01/10/2006
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Anticipated end date
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30/09/2015
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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780
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Interventions
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Radioiodine treatment versus usual care.
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Primary outcome measure(s)
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Composite circulatory mortality
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Secondary outcome measure(s)
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1. All cause mortality
2. Atrial fibrillation
3. Progression to overt
hyperthyroidism
4. Hip and vertebral fractures
5. MMTS
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Contact name
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Dr
Simon
Pearce
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Address
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School of Clinical Medical Sciences
University of Newcastle
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Email
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s.h.s.pearce@ncl.ac.uk
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Sponsor
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Newcastle upon Tyne Hospitals NHS Trust (UK)
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Address
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Research and Development Department
Clinical Research Facility
Leazes Wing, 4th Floor
Royal Victoria Infirmary
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE1 4LP
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Country
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United Kingdom
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Date applied
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16/12/2005
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Last edited
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28/04/2008
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Date ISRCTN assigned
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08/08/2006
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