Amlodipine for Myocardial Iron in Thalassemia

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Children with thalassemia may have high iron levels after receiving blood transfusions. These high iron levels can have damaging effects on the body, especially the heart. Conventionally only chelation therapy was given for prevention of iron buildup in the heart. However, current research has shown that another drug, amlodipine, also helps to slow down the deposition of iron in the heart. This study is designed to see if patients receiving amlodipine along with their regular chelation therapy have a slower rate of iron buildup in the heart when compared with patients who are receiving chelation only.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: Amlodipine; Calcium Channel Blockers; Deferasirox; Deferiprone; Deferoxamine

Criteria

Inclusion Criteria:

• Pediatric patients aged ≥ 6 and ≤ 20 years managed at AKUH for at least 1 year

• ≥ 10 blood transfusion in life time

• Transfusion need ≥ 180 ml/kg/year

• Serum ferritin ≥ 1000 ug/dl

• Patient deemed capable of receiving chelation therapy (by treating hematologist) either subcutaneous infusion of Deferoxamine (Desferal) (3-5 days a week) or oral deferasirox (daily) or Defeperione (oral) or a combination of Desferal and Defeperione.

• Patients who have been on a stable chelation regimen ≥ 6 months

• Completed and signed Informed consent/assent.

Exclusion Criteria:

• Patients with known hypersensitivity to amlodipine.

• Patients with known sinoatrial nodal disease or aortic stenosis.

• Patients with known severe myocardial dysfunction, defined as A LV ejection fraction of ≤ 4 SD for age even without symptoms.

• Patients with known signs and symptoms of heart failure.

• Patients with a T2* value of < 4 ms on cardiac MRI.

• Patients with systolic blood pressures ≤ 2 SD for age (systemic hypotension) at the time of enrolment.

• Patients with previously diagnosed significant congenital heart diseases or acquired heart diseases other than thalassemia (as defined earlier).

• Patients with known contraindications to MRI (pacemakers, cerebral aneurysm metal clips, etc.)

• Patient with a known history of developing tetany after use of a calcium channel blocker

• Known pregnancy.