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Completed

NCT Number: NCT05012631

Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease

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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Losartan

Drug

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.

Primary outcomes

  1. Change in extracellular volume fraction (ECV) after 1 year of losartan treatment

    Time frame: after 1 year of losartan treatment.

    Efficacy of losartan in stabilizing or reducing ECV (diffuse myocardial fibrosis) in SCD after one year.

Secondary outcomes

  1. Change in Diastolic Function

    Time frame: after 1 year of losartan treatment.

    Efficacy of losartan in improving diastolic function defined by echocardiographic and tissue Doppler assessment .

  2. Change in Exercise Capacity

    Time frame: after 1 year of losartan treatment.

    Efficacy of losartan in improving cardiopulmonary exercise testing (CPET) measurements.

  3. Predicting Myocardial Fibrosis

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2021
Registry last updated
Jun 12, 2026

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.

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