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Losartan for Stabilizing Extracellular Volume Fraction in Sickle Cell Disease Patients

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Study Aim

This phase 2 study aims to evaluate if Losartan treatment can stabilize or reduce extracellular volume fraction, a marker of diffuse myocardial fibrosis, in patients with sickle cell disease after one year.

What is being tested

Losartan

Drug
Who is being recruted

Anemia+6

+ Anemia, Hemolytic

+ Anemia, Hemolytic, Congenital

Over 6 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorChildren's Hospital Medical Center, Cincinnati
Study ContactOmar Niss, MDMore contacts
Last updated: March 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2021

Actual date on which the first participant was enrolled.

This is a phase II study focusing on a medication called losartan, which is used to block a certain type of receptor in the body. The study aims to help patients who are 6 years or older and have Sickle Cell Disease (SCD). The main goal is to gather data on the safety and effectiveness of losartan in managing or reducing a condition called diffuse myocardial fibrosis, which is associated with SCD. This research is important as it could potentially lead to improved care for individuals with Sickle Cell Disease. The study will enroll 24 patients over a year and will last for 2 years in total. Participants will take losartan for 12 months. The study's primary outcome is to measure changes in extracellular volume fraction (ECV), an indicator of diffuse myocardial fibrosis, after one year of treatment with losartan. This will help determine if losartan is effective in managing this condition for individuals with Sickle Cell Disease.

Official TitleLosartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.
NCT05012631
Principal SponsorChildren's Hospital Medical Center, Cincinnati
Study ContactOmar Niss, MDMore contacts
Last updated: March 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, HemolyticAnemia, Hemolytic, CongenitalAnemia, Sickle CellHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Criteria

Inclusion Criteria: 1. 6 years old or older 2. Diagnosis of HbSS or Sbeta0-thalassemia 3. Ability to cooperate with and undergo CMR without sedation or anesthesia 4. Ability to cooperate with and undergo echocardiogram without sedation or anesthesia 5. 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: 1. Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion 2. SCD genotypes other than specified in inclusion criteria 3. Any contraindication to CMR such as metallic implants 4. Inability to cooperate with CMR or echocardiography imaging 5. Known congenital heart disease 6. Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance 7. Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study 8. Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment 9. Hypersensitivity to angiotensin receptor II blockers 10. Hyperkalemia (K\>5.5 mEq/L) on a non-hemolyzed sample despite low-potassium diet 11. Hepatic dysfunction defined as serum ALT \> 5x the upper normal limit for age 12. Current lithium therapy 13. Chronic daily use of NSAID 14. HIV infection.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive oral losartan as tablets or oral solution one time daily. The dosing will depend on age and will be based on drug label and dosing used in studies on patients with SCD.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cincinnati Children's Hospital Medical Center

Cincinnati, United StatesOpen Cincinnati Children's Hospital Medical Center in Google Maps
Recruiting
One Study Center
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