Clinical trial Recruiting at 1 site Interventional Ages 4 to 15

Levothyroxine for heart function in children with subclinical hypothyroidism

Official title: The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism

Run by Tanta University · NCT07393165 · Data updated 2026-11-12

This trial will test whether levothyroxine improves heart function in children aged 4–15 who have subclinical hypothyroidism.

Quick facts

Study typeInterventional
Ages4 Years to 15 Years
SexAll
Enrollment40 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, El-Gharbia)
StatusRecruiting
StartedMay 24, 2025
Main results expectedMay 1, 2026
Study endsMay 1, 2026
Registry record updatedFebruary 6, 2026
Trial IDNCT07393165 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 4 to 15 with stable elevated TSH (≥4.5 mIU/L) and normal free T4 and FT3 on repeat testing, who do not meet any exclusion criteria, are ideal candidates.

Probably not a fit

Children with obesity, hypertension, known arrhythmia or congenital/acquired heart disease, prior recent levothyroxine or relevant medication use, or significant systemic illnesses are excluded and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children with subclinical hypothyroidism (elevated TSH with normal free T4 and FT3) will receive levothyroxine and undergo repeated cardiac evaluations to see how treatment affects heart function. Eligibility requires stable elevated TSH (≥4.5 mIU/L) confirmed 4–6 weeks apart and excludes obesity, hypertension, prior thyroid or cardiac drug use, and known heart, liver, kidney, metabolic, infectious, respiratory, or malignant disease. Cardiac outcomes will be monitored with clinical exams and imaging or functional cardiac tests at the treating center, alongside thyroid function monitoring. The intervention is administered at Tanta University and follows an interventional protocol to compare pre- and post-treatment cardiac measures.

Why it matters

Potential benefit: If successful, treatment could improve cardiac function and reduce early cardiovascular risk markers in affected children.

How similar studies have gone: Some adult studies report modest cardiac improvements with levothyroxine in subclinical hypothyroidism, but pediatric data are limited and results have been mixed.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age from 4 to 15 years.
* Both sexes.
* Patients with stable elevated thyroid-stimulating hormone (TSH) ≥ 4.5 mIU/L with normal free T4 and ft3 in different measurement 4 - 6 weeks apart.

Exclusion Criteria:

* Overweight and obesity
* Hypertension
* Previous use of levothyroxine, antiepileptic drugs, or cardiac drugs within the last 6 months.
* Arrhythmia.
* Congenital or acquired heart disease
* Liver or kidney disease
* Hyperlipidemia
* Diabetes
* Infectious diseases
* Respiratory diseases
* Malignancies

Where it's running

  • Tanta University
    Tanta, El-Gharbia, Egypt
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.