Effect of combination therapy with oral iron chelators on Heart functio
Phase 4
Completed
- Conditions
- Health Condition 1: D561- Beta thalassemia
- Registration Number
- CTRI/2020/07/026771
- Lead Sponsor
- KAHER J N Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in cardiac funtion as assessed by Echocardiography and tissue doppler imagingTimepoint: following 6 months treatment
- Secondary Outcome Measures
Name Time Method 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