Losartan for Stabilizing Extracellular Volume Fraction in Sickle Cell Disease Patients
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.
Losartan
Anemia+6
+ Anemia, Hemolytic
+ Anemia, Hemolytic, Congenital
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Cincinnati Children's Hospital Medical Center
Cincinnati, United StatesOpen Cincinnati Children's Hospital Medical Center in Google Maps