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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).

Effect of calcium channel blockers in combination with iron chelation therapy in patients with thalassemia major: A randomized double blind placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019787
Enrollment
68
Registered
2019-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: amlodipine: Patients will be randomized into one of the two groups using random numbers. Allocation will be done using serially numbered opaque and sealed envelopes. One group will rece

Sponsors

Department of Pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Patients with congenital or acquired heart disease 2. Patients with significant renal disease (serum creatinine >3 times normal or eGFR 3. Patients with significant liver disease (ALT/AST >3 times normal)

Design outcomes

Primary

MeasureTime frame
Percent change in myocardial iron concentrationTimepoint: 0, 6, 12 months—

Secondary

MeasureTime frame
Percent change in liver iron concentration Percent change in serum ferritin value Change in LVEF at 12 monthsTimepoint: 0, 6, 12 months—

Countries

India

Contacts

Public ContactVibhesh Raj

Department of Pediatrics, Institute of Medical Sciences

vineetaguptabhu@gmail.com05422317060

Outcome results

None listed

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