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NCT Number: NCT07393165

Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism

This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.

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Key information

Conditions

Levothyroxine Cardiac Function Children Subclinical Hypothyroidism

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Dina E Abd EL hai, MD

SUB_INVESTIGATOR

Doaa M EL Amrousy, MD

SUB_INVESTIGATOR

Ola A Taha, MD

SUB_INVESTIGATOR

Zeinab E Elshareef, MBBCH

CONTACT

[email protected]

00201001700194

About this study

Subclinical hypothyroidism (SH) is a branch of hypothyroidism which is characterized by increased thyroid stimulating hormone (TSH) and normal thyroxine (T4).

Inadequate serum thyroid hormone levels impair cardiac function and may result in multiple cardiovascular risk factors, such as endothelial dysfunction, increased intima-media thickness, increased vascular resistance, and pericardial effusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Thyroxine

Drug

Children with subclinical hypothyroidism who will receive L-thyroxine treatment in a dose of 2μg/kg/d (the smallest dose can be given) and the dose will be titrated every 4 weeks until a normal thyroid-stimulating hormone (TSH) level is maintained.

Primary outcomes

  1. Assessment of left ventricle systolic function

    Time frame: 3 months post-procedure

    Left ventricle systolic function will be measured using left ventricle (LV) ejection fraction (LV EF%) where: (LV EF%) = (LVEDD)³ - (LVESD) / (LVEDD)³×100% LVEDD=left ventricular end-diastolic dimension. LVESD=left ventricular end-systolic dimension. LVFS=LV fractional shortening.

Secondary outcomes

  1. Assessment of left ventricle fractional shortening

    Time frame: 3 months post-procedure

    Left ventricle fractional shortening (LV FS) will be measured. where: LV FS= LVEDD-LVESD/LVEDD X 100%.

    LVEDD=left ventricular end-diastolic dimension. LVESD=left ventricular end-systolic dimension.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeinab E Elshareef, MBBCH

CONTACT

[email protected]

00201001700194

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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