Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT05012631
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.
Looking for future studies?
Notify Me6 year and older
All sexes
Interventional
Phase 2
Cincinnati, Ohio, 45229, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Efficacy of losartan in improving diastolic function defined by echocardiographic and tissue Doppler assessment .
Time frame: after 1 year of losartan treatment.
Efficacy of losartan in improving cardiopulmonary exercise testing (CPET) measurements.
Time frame: At baseline and after one year of losartan treaement
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.
Children's Hospital Medical Center, Cincinnati
Other
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04691323
Anemia, Anemia, Hemolytic
Chicago, Illinois, United States
View Trial DetailsNCT04688411
Anemia, Anemia, Hemolytic
Chicago, Illinois, United States
View Trial DetailsNCT05405114
Anemia, Anemia, Hemolytic
Mobile, Alabama, United States
View Trial DetailsNCT07721155
Anemia, Anemia, Hemolytic
Amsterdam, Netherlands
View Trial Details