Effects of amlodipine on myocardial iron deposition in pediatric patients with thalassemia major

Phase 2

• Conditions: Haematological Disorders; Paediatrics

• Registration Number: PACTR201902478249291
• Lead Sponsor: Beni suef university hospital

Brief Summary

After 6 months, a significant reduction was noted in the MIC of patients receiving amlodipine (n=20), compared with the patients receiving the placebo (n=20). At baseline, the mean was 0.76±0.11 mg/g dry weight, while at 6 months, the mean was 0.51±0.07 mg/g dry weight (p< 0.001). Also, there was a significant change in the myocardial T2* after 6 months; the amlodipine increased the myocardial T2* from 40.63±5.45 ms at baseline to 43.25±5.35 ms (p< 0.001). However, amlodipine did not significantly affect the secondary outcomes by the end of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-02
• Results First Posted: 2019-02-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients eligible for enrollment at baseline were male or female aged between 6 and 18 years old with ß-Thalassemia major.
Potential participants had been diagnosed with thalassemia major (TM), as confirmed by the presence of microcytic hypochromic anemia and hemoglobin electrophoresis;
additionally, patients who had been receiving a regular blood transfusion during the last two years,
with a serum ferritin (SF) level more than 1000 ng /ml were also considered.

Exclusion Criteria

Participants were excluded if they were more than 20 years old,
their SF was less than 1000 ng /ml,
they experienced heart failure (ejection fraction (EF) less than 30%),
they were contraindicated to undergo the magnetic resonance imaging (MRI) scan,
or they were expected to change their chelation therapy regimen during the next 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary trial endpoint was the change in the MIC and cardiac T2* after 6 months in either the placebo or treatment group. Efficacy data were analyzed as changes from core baseline to month 6

Secondary Outcome Measures

Name	Time	Method
The secondary trial endpoint were potential changes in the liver iron concentration , liver T2*, serum ferritin level , and left ventricle ejection fraction after 6 months of treatment in either group.