NCT05012631CompletedPhase 2
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 15 Jul 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 3 Oct 2025
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Sickle cell disease
- NCT number
- NCT05012631
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 14
- From 1 Sept 2021 to the primary completion date, 3 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
- Any contraindication to CMR such as metallic implants
- Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment
- Current lithium therapy
Other illness
- Known congenital heart disease
- Hypersensitivity to angiotensin receptor II blockers
- HIV infection.
Lab values
- Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance
- 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
Other
- SCD genotypes other than specified in inclusion criteria
- Inability to cooperate with CMR or echocardiography imaging
- Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study
- Chronic daily use of NSAID
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.