Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease
Status:
Completed
Trial end date:
2018-01-09
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to learn about the effect of the drug, atorvastatin, on
blood vessels in patients with sickle cell disease.
The primary hypothesis is that endothelial dysfunction is an important contributor to the
pathophysiology of albuminuria in SCD. The investigators propose that atorvastatin will
improve endothelial dysfunction, decrease levels of soluble fms-like tyrosine kinase-1
(sFLT-1), and decrease albuminuria in SCD patients.
Participants will be individuals with sickle cell disease, age 18 to 60, who have some degree
of albuminuria. A total of 19 subjects, males and females, will be enrolled. The study is
made up of Screening, Treatment, and Follow Up phases and has a cross-over design. After
patients are screened for eligibility, they will be randomized to receive atorvastatin or
placebo in the initial six-week treatment period. When that is complete, there will be a
four-week washout period before they begin another six-week treatment period. In the second
treatment period, they "cross-over" to the other treatment arm. Four weeks after the end of
the second treatment period, follow-up safety assessments will be done.