Effect of combination of calcium channel blocking drugs and iron lowering drugs on iron levels in patients with thalassemia major (blood disorder requiring repeated blood transfusions).
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: D561- Beta thalassemia
- Registration Number
- CTRI/2019/06/019787
- Lead Sponsor
- Department of Pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with serum ferritin >1000 ng/ml
2. Received >10 blood transfusions
3. Patients on stable iron chelation for >6 months
Exclusion Criteria
1. Patients with congenital or acquired heart disease
2. Patients with significant renal disease (serum creatinine >3 times normal or eGFR <30 ml/min/m2)
3. Patients with significant liver disease (ALT/AST >3 times normal)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in myocardial iron concentrationTimepoint: 0, 6, 12 months
- Secondary Outcome Measures
Name Time Method Percent change in liver iron concentration <br/ ><br>Percent change in serum ferritin value <br/ ><br>Change in LVEF at 12 monthsTimepoint: 0, 6, 12 months