This study is a pilot, phase II, open-label study of the angiotensin II receptor blocker, losartan, in patients with Sickle Cell Disease (SCD) 6 years or older for 12 months. The investigators will enroll 24 patients with SCD over the course of 1 year with a goal to complete all study procedures in 2 years. The short-term goal is to obtain clinical pilot data regarding the safety and efficacy of losartan in stabilizing or decreasing extracellular volume fraction (ECV) after 12 months of therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Losartan dosing for participants \<16 years will be 0.7 mg/kg (maximum of 50 mg) once daily. The dose can be increased to 1.4 mg/kg (maximum of 100 mg once daily) after 2 weeks if the dose was tolerated (no hypotension or hyperkalemia). For patients ≥16 years, the starting dose will be 50 mg once daily which can be increased to 100 mg daily if tolerated after 2 weeks.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGChange in extracellular volume fraction (ECV) after 1 year of losartan treatment
Efficacy of losartan in stabilizing or reducing ECV (diffuse myocardial fibrosis) in SCD after one year.
Time frame: after 1 year of losartan treatment.
Change in Diastolic Function
Efficacy of losartan in improving diastolic function defined by echocardiographic and tissue Doppler assessment .
Time frame: after 1 year of losartan treatment.
Change in Exercise Capacity
Efficacy of losartan in improving cardiopulmonary exercise testing (CPET) measurements.
Time frame: after 1 year of losartan treatment.
Predicting Myocardial Fibrosis
Explore the performance characteristics of the following serum biomarkers in predicting myocardial fibrosis in patients with SCD: PICP, PIIINP, TGF-β, CTGF, soluble ST2, galectin-3, and NT-proBNP.
Time frame: At baseline and after one year of losartan treaement
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