Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.
Children's Hospital Medical Center, Cincinnati
24 participants
Sep 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria17
- 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.
- 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.
Exclusion Criteria1
- Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05012631