Losartan for Sickle Cell Disease

Overseen By Amanda Pfeiffer

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Must be taking: Sickle cell therapies

Must not be taking: Renin-angiotensin inhibitors, Lithium, NSAIDs

Disqualifiers: Chronic transfusion, Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing losartan, a blood pressure medication, in patients aged 6 and older with Sickle Cell Disease. The goal is to see if it can safely reduce fluid buildup in the body over time.

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

I have been on a stable dose of medication for sickle cell disease for 3 months.

You are able to undergo an echocardiogram without needing to be asleep or numb.

I am 6 years old or older.

Exclusion Criteria

My sickle cell disease genotype is not listed in the study's accepted types.

Inability to cooperate with CMR or echocardiography imaging

You are allergic to angiotensin receptor II blockers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of myocardial fibrosis and exercise capacity

4 weeks

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?

Group I: Losartan Experimental Treatment 1 Intervention

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:

Approved in United States as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Stroke prevention in hypertension and left ventricular hypertrophy

Approved in European Union as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Approved in Canada as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+