What side effects are associated with this type of intervention?

The most common treatments for Sickle Cell Disease include hydroxyurea, red blood cell transfusions, and pain management medications. Hydroxyurea, the first-line therapy, can cause side effects such as bone marrow suppression, leading to low blood counts, and gastrointestinal issues. Red blood cell transfusions can lead to iron overload and alloimmunization. Pain management often involves opioids, which carry risks of dependency and other side effects like constipation and nausea. Angiotensin II Receptor Blockers (ARBs) like Losartan, studied for their potential benefits in SCD, generally have side effects including dizziness, hyperkalemia, and renal impairment. However, specific data on ARBs in SCD is limited.

What prior FDA approvals exist?

Hydroxyurea is a well-established FDA-approved treatment for Sickle Cell Disease, known for reducing vaso-occlusive pain and other complications. It has demonstrated efficacy in improving survival and quality of life. Additionally, chronic transfusion therapy is another FDA-approved approach for preventing stroke in SCD patients. While the context mentions a pilot study on Losartan, an Angiotensin II Receptor Blocker, for its potential benefits in SCD, there is no specific FDA approval for ARBs in SCD treatment as of now.

What other types of research exist?

Promising novel alternatives to Losartan for Sickle Cell Disease patients include Hydroxyurea, which is recommended for its efficacy in reducing vaso-occlusive pain and other complications. Additionally, new medications that modify the pathogenesis of SCD-associated vaso-occlusion are emerging as potential alternatives.

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Angiotensin II Receptor Blocker

Losartan for Sickle Cell Disease

Phase 2

Recruiting

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6 years old or older

Diagnosis of HbSS or Sbeta0-thalassemia

Must not have

SCD genotypes other than specified in inclusion criteria

Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 year of losartan treatment.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Losartan may cause side effects such as dizziness due to low blood pressure, increased potassium levels which can affect heart rhythm, mild swelling of legs and arms, fatigue, nausea or stomach pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 6 years old or older.

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I have been diagnosed with HbSS or Sbeta0-thalassemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not pregnant or breastfeeding and can use birth control during the study.

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My kidney function is low, with a GFR of 30 mL/min/1.73 m^2 or less.

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I was born with a heart condition.

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I have been treated with a renin-angiotensin inhibitor in the last 2 weeks.

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I am HIV positive.

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I am currently taking lithium.

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My liver enzyme ALT levels are more than five times the normal limit.

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I use NSAID pain relievers every day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and after one year of losartan treaement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and after one year of losartan treaement

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and after one year of losartan treaement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in extracellular volume fraction (ECV) after 1 year of losartan treatment

Secondary study objectives

Change in Diastolic Function

Change in Exercise Capacity

Predicting Myocardial Fibrosis

Side effects data

From 2021 Phase 4 trial • 227 Patients • NCT02188121

43%

Laboratory values outside normal range

23%

Psychiatric Hospitalization

Medical Hospitalization

Elevated creatine kinase level

Muscle pain

Hypotension

Dehydration

Leukemia

Placed on Lithium while on Losartan

100%

80%

60%

40%

20%

Study treatment Arm

Statin and/or Angiotensin Receptor Blocker

Usual Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LosartanExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sickle Cell Disease (SCD) include hydroxyurea, red blood cell transfusions, and angiotensin-converting enzyme (ACE) inhibitors. Hydroxyurea works by increasing fetal hemoglobin (Hb F) production, which reduces the sickling of red blood cells and decreases vaso-occlusive events. Red blood cell transfusions help to dilute the sickled cells and improve oxygen delivery. ACE inhibitors, and potentially ARBs like Losartan, are used to manage complications such as proteinuria and diffuse myocardial fibrosis by reducing blood pressure and decreasing the strain on the heart and kidneys. These treatments are crucial for SCD patients as they help to manage pain, prevent complications, and improve overall quality of life.

Angiotensin-converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease.Evolution of novel small-molecule therapeutics targeting sickle cell vasculopathy.