Effect of combination therapy with oral iron chelators on Heart function

Efficacy of combination therapy with oral iron chelators in children with transfusion dependant Beta-thalassemia major on assessing cardiac function by echocardiography and tissue doppler imaging- a hospital based open labelled randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026771

Enrollment

Registered

2020-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

Intervention1: Combination therapy: Deferiprone dose 75mg/kg/day frequency 8th Hourly route of administration oral duration 6 months Deferasirox dose 30mg/kg/day frequency 24th hourly route of ad

Eligibility

Inclusion criteria

Inclusion criteria: Transfusion dependent Beta-Thalassemia Major Patients between 10-18 years of age, on a single oral iron chelator (Deferasirox) with abnormal ECHO findings.

Exclusion criteria

Exclusion criteria: 1.Patients on more than 1 oral iron chelator 2. Congenital heart disease 3. Rheumatic heart disease 4. Other haemoglobinopathies like sickle cell disease 5. Chronic infections like TB, HIV, HEP-C, HEP-B 6. Raised serum transaminase levels ( more than 5 times the upper normal limit) 7. History of allergy to either drugs.

Design outcomes

Primary

Measure	Time frame
Differences in cardiac funtion as assessed by Echocardiography and tissue doppler imagingTimepoint: following 6 months treatment	—

Secondary

Measure	Time frame
Changes in Complete Blood Count parametersTimepoint: following 1, 2, 3, 4, 5 and 6 months treatment;Changes in Liver and Kidney Function parametersTimepoint: following 6 months treatment;Changes in Serum Ferritin levelsTimepoint: following 6 months treatment;Decrease in Liver and Spleen size as assessed by Ultrasound examinationTimepoint: following 6 months treatment	—

Countries

India

Contacts

Public ContactDr Neha Goudar

J N Medical College

drsmjali@gmail.com9845688999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026