Clinical Importance of Treating Iron Overload in Sickle Cell Disease
Status:
Terminated
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Hypothesis:
The investigators suspect that significant degrees of iron overload in subjects with SCD
result in decreased red cell survival, abnormal endothelial function and markedly
dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude
of these effects is proportional not only to the magnitude of total body iron stores but also
to the duration of exposure to the high iron levels in tissues.
Primary objective To determine if red cell survival as assessed by 51Cr red cell survival
analysis, hemoglobin level, reticulocyte count, lactic acid dehydrogenase, and plasma
hemoglobin in sickle cell patients is related to the degree of iron overload.
Secondary objective(s)
1. Determine if the magnitude of endothelial-dependant vasodilation is related to The
degree of iron overload.
2. Determine if the degree of change in cardiac beat to beat variability in response to
hypoxic exposure or to cold exposure ("cold-face-test") is related the magnitude of iron
overload.
The primary measure of iron overload will be MRI determination of liver iron concentration.