Cardiovascular Diseases Clinical Trial
Official title:
Thalassemia Clinical Research Network - Cardiac L1/DFO Trial
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.
DESIGN NARRATIVE:
Participants will be randomized to 1 year of treatment with L1/DFO combination therapy or DFO
monotherapy. At baseline, 6 months, and 1 year on therapy, cardiac function will be assessed
by MRI measurement of left ventricular ejection fraction (LVEF), T2*, Holter monitoring, and
electrocardiography. Additional monitoring for safety includes weekly blood testing, monthly
visits, and periodic eye and ear exams.
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