Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases

Phase 2 Terminated 20 enrolled Carelon Research National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims include evaluating changes in myocardial iron burden using T2\* and estimating the relative incidence and severity of chelator-induced toxicity.

Timeline

Start: 2005-06
Primary completion: 2008-07
Completion: 2009-04

Publications

Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deferiprone	Small molecule	75 mg/kg	Oral
Subject	Deferoxamine	Other / unclassified	50 mg/kg	Subcutaneous
Subject	Deferoxamine	Other / unclassified	60 mg/kg	Subcutaneous

Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases

Summary

Timeline

Publications

Drugs

Indications