Thyroid Hormone Replacement for Subclinical Hypothyroidism
Information source: NHS Greater Glasgow and Clyde
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subclinical Hypothyroidism
Intervention: Levothyroxine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: NHS Greater Glasgow and Clyde Official(s) and/or principal investigator(s): David J Stott, MBChB MD, Principal Investigator, Affiliation: University of Glasgow Jacobijn Gussekloo, MD, Principal Investigator, Affiliation: Leiden University Medical Center Nicolas Rodondi, MD, Principal Investigator, Affiliation: University of Bern Patricia Kearney, MD, Principal Investigator, Affiliation: University College Cork Rudi JG Westendorp, MD, Principal Investigator, Affiliation: University of Copenhagen
Overall contact: David J Stott, MBChB MD, Phone: 441412114976, Email: david.j.stott@glasgow.ac.uk
Summary
Subclinical hypothyroidism (SCH) is a common condition among older men and women. Although
by definition SCH comprises biochemically mild thyroid hormone deficiency without overt
symptoms, it is a possible contributor to multiple problems in older age. Thyroid hormone
has effects on numerous physiological systems, including the vascular tree, heart, skeletal
muscle and brain. Therefore, thyroxine substitution to overcome thyroid hormone deficiency
has the potential to give multisystem benefits to older people with SCH.
Small studies have reported reduced atherosclerosis and improved heart function with
thyroxine replacement, but no large clinical trials have been performed. Therefore the
available evidence is limited, leading to major variations in guidelines and clinical
practice, with uncertainty regarding the indications for screening and treatment. The
investigators propose a multicentre randomised placebo controlled trial to assess the impact
of thyroxine replacement in 540 older adults with persisting SCH (excluding those in whom it
is a temporary phenomenon who are unlikely to benefit). The investigators will include older
men and women with a wide age range and of varying health status. Outcomes include health
related quality of life, muscle strength, executive cognitive function and cardiovascular
events, with a minimum of 1 year of follow up. Blood and urine samples will be stored in a
biobank, to allow future research on causes of ill health in older people with SCH.
The investigators have the support of patient advocacy groups and a consortium with the wide
range of expertise and experience required to conduct large scale multicentre clinical
trials. The proposal explores the multisystem and quality of life benefits to older people
of a tailored approach to management of SCH.
This clinical trial should definitively clarify whether thyroxine treatment for SCH provides
benefits that are relevant for patients. This trial will provide strong evidence with the
potential to improve clinical practice, reduce health care costs and promote healthy ageing
of older adults.
Clinical Details
Official title: Multi-modal Effects of Thyroid Hormone Replacement for Untreated Older Adults With Subclinical Hypothyroidism; a Randomised Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Thyroid-specific quality of life
Secondary outcome: Health-related quality of lifeHandgrip strength Executive cognitive function Total mortality Basic Activities of Daily Living Extended activities of daily living Haemoglobin Fatal and non-fatal cardiovascular events
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Community-dwelling patients aged >=65 years with Subclinical Hypothyroidism (SCH).
SCH is defined as elevated TSH levels (>=4. 6, <=19. 9 mU/L) and free thyroxine (fT4) in
reference range measured on a minimum of two occasions at least 3 months apart.
Exclusion Criteria:
- Subjects currently on Levothyroxine or antithyroid drugs, amiodarone or lithium.
- Recent thyroid surgery or radio-iodine (within 12 months).
- Grade IV NYHA heart failure.
- Prior clinical diagnosis of dementia.
- Recent hospitalisation for major illness or elective surgery (within 4 weeks).
- Recent acute coronary syndrome, including myocardial infarction or unstable angina
(within 4 weeks).
- Terminal illness.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption.
- Subjects who are participating in ongoing RCTs of therapeutic interventions
(including CTIMPs)
- Plan to move out of the region in which the trial is being conducted within the next
2 years (proposed minimum follow-up period).
Locations and Contacts
David J Stott, MBChB MD, Phone: 441412114976, Email: david.j.stott@glasgow.ac.uk
Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow G31 2ER, United Kingdom; Recruiting David J Stott, MBChB, MD, Phone: +44 (0)1412018515, Email: david.j.stott@glasgow.ac.uk David J Stott, MBChB, Principal Investigator Terry J Quinn, MBChB(hons), Sub-Investigator
Additional Information
Starting date: May 2014
Last updated: July 1, 2015
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