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T3-4-Hypo trial
EU CTIS ID: 2024-513883-24-00
What this study is testing
To investigate the effects of LT4/LT3 combination therapy compared to LT4 monotherapy on tiredness in those patients with autoimmune hypothyroidism and persisting tiredness on LT4 monotherapy, after 1 year of treatment. In case it is confirmed that LT4/LT3 combination therapy reduces tiredness compared to LT4 treatment alone, the primary objective includes investigating simultaneously whether effect sizes are higher in patients with genetic variation in the type 2 deiodinase (DIO2-rs225014) and effect sizes are higher in patients with genetic variation in the monocarboxylate transporter 10 (MCT10-rs17606253).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with overt or subclinical hypothyroidism 18 years or older.LT4 monotherapy for at least 6 months.LT4 monotherapy dose of 75-225 microg, with at least a dose of 1.2microg/kg. TSH levels within the assay-specific reference ranges for at least 3 months. Severe tiredness with a large negative impact on daily life for at least 6months, with or without other persisting complaints. This is based on the patient's own experience, without judgment of the treating physician. Sufficiently fluent in Dutch and able to read Dutch.
You likely can't join if
- Thyroid surgery Radioactive iodine treatment Use of thyroid interfering drugs (current/past use of amiodarone, immunotherapy, tyrosin kinase inhibitors, interferon or lithium and current use of oral or iv corticosteroids or dopamine) Current psychiatric disease treated at a "gespecialiseerde GGZ instelling" Clinical diagnosis of dementia Pregnancy, breastfeeding or wish to become pregnant within 2 years Current/past atrial fibrillation Functional or structural abnormal heart (e.g. cardiomyopathy or valve disease) Current conduction disorder on ECG (i.e. Prolonged QRS > 100 ms; or prolonged QTc; QTc women > 460 msec / men > 450 msec) Frequentventricular extrasystole (=doublet, trigeminy, bigeminy or (non-sustained) ventricular tachycardia) in the past or on current ECG Recent acute coronary syndrome or unstable angina pectoris (< 4 weeks) Other obvious medical explanation for tiredness (e.g. end-stage renal disease, anemia, COPD stage IV, cancer, etc.) Other obvious major life event explanation for tiredness (e.g. mourning, loss of job)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.