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IEMO 80-plus thyroid trial.


- candidate number14367
- NTR NumberNTR3851
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-feb-2013
- Secondary IDs2012-004160-22 EudraCT
- Public TitleIEMO 80-plus thyroid trial.
- Scientific TitleIEMO 80-plus thyroid trial.
- ACRONYM
- hypothesis1. Does Levothyroxine treatment for subclinical hypothyroidism give multi-modal benefits for the oldest old people with subclinical hypothyroidism?
2. Are benefits seen across a wide range of outcomes, including prevention of cardiovascular disease, and improving health-related quality of life, muscle function and cognition?
3. Are benefits seen in specific subgroups of oldest old people with subclinical hypothyroidism, including women, and those with mild degrees of subclinical hypothyroidism (TSH 4.6-10 mU/L)?
4. Are any benefits offset by adverse effects, such as atrial fibrillation or heart failure?
- Healt Condition(s) or Problem(s) studiedLevothyroxine, Older adults, Subclinical hypothyroidism
- Inclusion criteriaCommunity-dwelling patients aged >80 years with SCH.

SCH is defined as persistently elevated TSH levels (>4.6 and ≤19.9 mU/L) and free thyroxine (fT4) in reference range measured on a minimum of two occasions at least 3 months apart.
- Exclusion criteria1. Subjects currently on Levothyroxine or antithyroid medication (e.g. Carbimazole, methimazole, propylthiouracil, potassium percholate), amiodarone or lithium;
2. Recent thyroid surgery or radio-iodine therapy (within 12 months);
3. Grade IV NYHA heart failure;
4. Prior clinical diagnosis of dementia;
5. Recent hospitalisation for major illness (within 4 weeks);
6. Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks);
7. Acute myocarditis ore acute pancarditis;
8. Untreated adrenal insufficiency;
9. Terminal illness;
10. Patients known to have rare hereditary problem of galactose intolerance;
11. Subjects who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products [CTIMPs]);
12. Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-mrt-2017
- Target number of participants450
- InterventionsOral Levothyroxine 50 g daily (reduced to 25 mcg daily in subjects < 50 kg body weight or if known coronary heart disease) versus matching placebo. The intervention will have a maximum of 3 years.
- Primary outcome1. Fatal and non-fatal cardiovascular events (this will include acute myocardial infarction; stroke; amputations for peripheral vascular disease; revascularisations for atherosclerotic vascular disease, including for acute coronary syndrome and heart failure hospitalisations);
2. Change in disease specific quality of life.
- Secondary outcome1. General quality of life;
2. Handgrip strength;
3. Cognitive function, particularly executive function;
4. Total mortality and cardiovascular mortality;
5. Functional ability (basic Activities of Daily Living (ADL); extended activities of daily living);
6. Gait speed;
7. Haemoglobin;
8. Depressive symptoms.
- TimepointsThe aim is to record 161 cardiovascular events over 1350 years of patient follow-up. It is anticipated that a minimum of 2 years of follow-up will be required with a likely average of 3 years for each patient.
- Trial web sitewww.iemoschildklierstudie.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Simon Mooijaart
- CONTACT for SCIENTIFIC QUERIES Simon Mooijaart
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground of the study:
Subclinical hypothyroidism is a common condition (8-18%) among older men and women. Although by definition subclinical hypothyroidism comprises biochemically mild thyroid hormone deficiency, 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 subclinical hypothyroidism. 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. This is especially the case for the oldest old, because observational studies are conflicting and very few oldest old are included in clinical trials, although they have the highest prevalence of subclinical hypothyroidism and its potentially related symptoms and diseases.

Objective of the study:
1. Does Levothyroxine treatment for subclinical hypothyroidism give multi-modal benefits for the oldest old people with subclinical hypothyroidism?

2. Are benefits seen across a wide range of outcomes, including prevention of cardiovascular disease, and improving health- related quality of life, muscle function and cognition?

3. Are benefits seen in specific subgroups of oldest old people with SCH, including women, and those with mild degrees of subclinical hypothyroidism (TSH 4.6-10 mU/L)?

4. Are any benefits offset by adverse effects, such as atrial fibrillation or heart failure?

Study design:
Randomised double-blind placebo-controlled parallel group trial.

Study population:
450 community-dwelling patients aged >80 years with subclinical hypothyroidism, diagnosed on the basis of persistently elevated TSH levels, measured on a minimum of two occasions at least 3 months apart, over 2 years.

Intervention:
Oral Levothyroxine 50 μg daily (reduced to 25 mcg daily in subjects < 50 kg body weight or if known coronary heart disease) versus matching placebo.

Primary study parameters/outcome of the study:
1. Fatal and non-fatal cardiovascular events (this will include acute myocardial infarction; stroke; amputations for peripheral vascular disease; revascularisations for atherosclerotic vascular disease, including for acute coronary syndrome and heart failure hospitalisations);
2. Change in disease specific quality of life.

Secundary study parameters/outcome of the study:
1. General quality of life
;
2. Handgrip strength
;
3. Cognitive function, particularly executive function;

 4. Total mortality and cardiovascular mortality
;
5. Functional ability (basic Activities of Daily Living (ADL); extended activities of daily living);
6. Gait speed
;
7. Haemoglobin
;
8. Depressive symptoms.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Adverse events (atrial fibrillation, heart failure and fractures in particular) are likely to occur only in the context of over replacement of Levothyroxine. Our dose titration scheme and study processes of careful monitoring of thyroid function tests are designed to ensure we avoid prolonged periods of thyroid hormone excess.
For the group allocated to placebo, there is risk of developing overt clinical hypothyroidism; however, our study processes of careful monitoring of thyroid function tests are designed to avoid this scenario.
- Main changes (audit trail)
- RECORD12-feb-2013 - 21-feb-2013


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