Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease (NCT05012631) | Clinical Trial Compass
CompletedPhase 2
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
United States14 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in extracellular volume fraction (ECV) after 1 year of losartan treatment
Timeframe: after 1 year of losartan treatment.
Trial details
NCT IDNCT05012631
SponsorChildren's Hospital Medical Center, Cincinnati
. 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