Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
Completed · Phase 2
Conditions studied: Sickle Cell Disease, Diffuse Myocardial Fibrosis
In brief
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.
Key facts
- Study ID
- NCT05012631
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 14
- Starts
- 2021-09-01
- Expected to finish
- 2026-05-28
- Last updated by the study team
- 2026-06-12
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 6 years old or older
- Diagnosis of HbSS or Sbeta0-thalassemia
- Ability to cooperate with and undergo CMR without sedation or anesthesia
- Ability to cooperate with and undergo echocardiogram without sedation or anesthesia
- Patients who are on a stable dose of sickle cell disease-modifying therapy: Hydroxyurea, Voxelotor, L-Glutamine, or Crizanlizumab, for 3 months prior to enrollment will be eligible.
You may not qualify if…
- Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
- SCD genotypes other than specified in inclusion criteria
- Any contraindication to CMR such as metallic implants
- Inability to cooperate with CMR or echocardiography imaging
- Known congenital heart disease
- Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance
- Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study
- Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment
- Hypersensitivity to angiotensin receptor II blockers
- Hyperkalemia (K>5.5 mEq/L) on a non-hemolyzed sample despite low-potassium diet
- Hepatic dysfunction defined as serum ALT > 5x the upper normal limit for age
- Current lithium therapy
- Chronic daily use of NSAID
- HIV infection.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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