Actively Recruiting
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-17
24
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 6 years old or older
- Diagnosis of HbSS or Sbeta0-thalassemia
- Ability to cooperate with and undergo cardiac magnetic resonance imaging without sedation or anesthesia
- Ability to cooperate with and undergo echocardiogram without sedation or anesthesia
- Stable dose of sickle cell disease-modifying therapy (Hydroxyurea, Voxelotor, L-Glutamine, or Crizanlizumab) for at least 3 months prior to enrollment
You will not qualify if you...
- Current chronic transfusion therapy (patients eligible 3 months after acute transfusion)
- Sickle cell disease genotypes other than HbSS or Sbeta0-thalassemia
- Contraindications to cardiac magnetic resonance imaging such as metallic implants
- Inability to cooperate with cardiac MRI or echocardiography imaging
- Known congenital heart disease
- Estimated glomerular filtration rate (GFR) 30 mL/min/1.73 m2 or lower
- Pregnancy or lactation, or inability to use medically accepted contraception if of child-bearing potential
- Treatment with renin-angiotensin pathway inhibitors within 2 weeks prior to enrollment
- Hypersensitivity to angiotensin receptor II blockers
- Hyperkalemia (potassium levels above 5.5 mEq/L) despite a low-potassium diet
- Liver dysfunction with ALT levels more than 5 times the upper normal limit for age
- Current lithium therapy
- Chronic daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
- HIV infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
O
Omar Niss, MD
CONTACT
A
Amanda Pfeiffer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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