Losartan for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the medication losartan might benefit people with Sickle Cell Disease (SCD). Researchers aim to determine if losartan is safe and effective in stabilizing or reducing a specific body fluid measure (extracellular volume fraction) over 12 months. The trial seeks individuals who are 6 years or older, have a specific type of SCD (such as HbSS or Sbeta0-thalassemia), and are already on stable SCD therapy. Participants must be able to complete certain heart imaging tests without sedation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
If you are on a stable dose of sickle cell disease-modifying therapy like Hydroxyurea, Voxelotor, L-Glutamine, or Crizanlizumab, you can continue taking them. However, you must stop any renin-angiotensin pathway inhibitors 2 weeks before joining the study and cannot be on chronic daily NSAIDs or lithium therapy.
Is there any evidence suggesting that losartan is likely to be safe for humans?
Research has shown that losartan has been tested in people with sickle cell disease (SCD) to assess its safety and effects. Some studies have examined whether losartan could help with kidney problems related to SCD. The trials found no major changes in heart or lung health, indicating that people generally tolerated it well.
The FDA has already approved losartan for treating high blood pressure and certain heart issues, confirming its safety for those conditions. While its effects in SCD might differ, existing evidence of its safety in other conditions suggests it could also be safe for people with SCD.12345Why do researchers think this study treatment might be promising for Sickle Cell Disease?
Unlike the standard treatments for sickle cell disease, which primarily focus on managing pain and preventing complications through blood transfusions and hydroxyurea, losartan offers a unique approach by targeting the renin-angiotensin system. Researchers are intrigued by losartan because it has the potential to improve blood flow and reduce the risk of organ damage by decreasing inflammation and blood vessel constriction. This mechanism of action is different from current treatments and could offer a significant benefit in protecting organs without relying solely on traditional pain management strategies.
What evidence suggests that losartan might be an effective treatment for Sickle Cell Disease?
Research has shown that losartan, primarily used for high blood pressure, might also benefit people with Sickle Cell Disease (SCD). In studies involving patients with sickle cell nephropathy, losartan reduced albuminuria, a marker of kidney damage, while maintaining stable kidney function. Although losartan has not improved heart-related issues in SCD, it is known to protect kidneys in conditions like diabetes. Researchers believe losartan might reduce heart strain in people with SCD. These early findings suggest potential benefits, but further research is necessary to confirm its effectiveness for SCD. Participants in this trial will receive oral losartan to explore these potential benefits further.12467
Are You a Good Fit for This Trial?
This trial is for patients 6 years or older with Sickle Cell Disease (SCD), specifically HbSS or Sbeta0-thalassemia. They must be able to undergo heart imaging without sedation and have been on a stable dose of certain SCD therapies for 3 months. Excluded are those on chronic transfusion therapy, with severe kidney issues, pregnant women not using contraception, and others listed in the exclusion criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral losartan daily for 12 months to assess its efficacy in stabilizing or decreasing extracellular volume fraction (ECV) in Sickle Cell Disease
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of myocardial fibrosis and exercise capacity
What Are the Treatments Tested in This Trial?
Interventions
- Losartan
Trial Overview
The study tests Losartan's safety and effectiveness in stabilizing or reducing heart muscle scarring over 12 months in SCD patients. It's an open-label pilot phase II trial enrolling 24 participants to gather preliminary data.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Losartan is already approved in United States, European Union, Canada for the following indications:
- Hypertension
- Diabetic nephropathy
- Stroke prevention in hypertension and left ventricular hypertrophy
- Hypertension
- Diabetic nephropathy
- Heart failure
- Hypertension
- Diabetic nephropathy
- Heart failure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT01989078?cond=Sickle%20cell%20nephropathy&viewType=Table&rank=8NCT01989078 | Losartan for Sickle Cell Kidney Disease
Losartan is an FDA-approved drug to treat blood pressure to protect the kidneys in people who have diseases like diabetes and blood pressure. It is not ...
Losartan for the Nephropathy of Sickle Cell Anemia
There were no changes in cardiopulmonary outcomes after losartan therapy. However, there were baseline differences in cardiac phenotype based on the presence or ...
Losartan therapy decreases albuminuria with stable ...
Losartan therapy for ≥ 1 year in sickle nephropathy results in lower albumin excretion with stable GFR. Filtration of neutral molecules ≥ 36 Å was not changed ...
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell ...
The short-term goal is to obtain clinical pilot data regarding the safety and efficacy of losartan in stabilizing or decreasing extracellular volume fraction ( ...
Losartan for the nephropathy of sickle cell anemia
Our primary hypothesis was that losartan therapy would decrease the degree of albuminuria by ≥25% in participants with microalbuminuria (MicroA) ...
6.
ashpublications.org
ashpublications.org/hematology/article/2023/1/519/506453/Using-disease-modifying-therapies-in-sickle-cellUsing disease-modifying therapies in sickle cell disease
This article reviews important historic and recent drug trials for SCD, highlighting regulatory agency–approved drug therapies and our approach to the use of ...
Losartan for Sickle Cell Disease
Losartan. Trial Overview The study tests Losartan's safety and effectiveness in stabilizing or reducing heart muscle scarring over 12 months in SCD patients.
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