Losartan for Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Fibrosis+3 More
Losartan - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called losartan can help reduce the amount of red blood cells in people with sickle cell disease.

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Eligible Conditions

  • Fibrosis
  • Sickle Cell Disease (SCD)
  • Diffuse Myocardial Fibrosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Losartan will improve 1 primary outcome and 3 secondary outcomes in patients with Fibrosis. Measurement will happen over the course of after 1 year of losartan treatment..

At baseline and after one year of losartan treaement
Predicting Myocardial Fibrosis
Year 1
Change in Diastolic Function
Change in Exercise Capacity
Change in extracellular volume fraction (ECV) after 1 year of losartan treatment

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Group A (Study Drug+SOC)
Hypotension (SBP<100)
19%
Body aches
6%
Transaminitis
6%
Cough
0%
Headache
0%
Malnutrition
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04340557) in the Group A (Study Drug+SOC) ARM group. Side effects include: Hypotension (SBP<100) with 19%, Body aches with 6%, Transaminitis with 6%, Cough with 0%, Headache with 0%.

Trial Design

1 Treatment Group

Losartan
1 of 1
Experimental Treatment

This trial requires 24 total participants across 1 different treatment group

This trial involves a single treatment. Losartan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Losartan
Drug
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline and after one year of losartan treaement
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at baseline and after one year of losartan treaement for reporting.

Closest Location

Cincinnati Children's Hospital Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Six years old and older. show original
CMR without sedation or anesthesia has been successfully completed in humans show original
in pediatric patients This text is saying that pediatric patients will be able to cooperate with and undergo echocardiograms without sedation or anesthesia. show original
Patients who are taking hydroxyurea, voxelotor, L-glutamine, or crizanlizumab for at least three months prior to enrolling in the study will be eligible. show original
Diagnosis of HbSS or Sbeta0-thalassemia

Patient Q&A Section

How many people get anemia, sickle cell a year in the United States?

"The prevalence of HbA(1c>6.0%) ≥6% (37%) is lower than the previous reports for anemia. The prevalence of sickle cell disease is similar to previous estimates. However, the prevalence of sickle cell disease with abnormal HbA(1c) is underestimated." - Anonymous Online Contributor

Unverified Answer

What is anemia, sickle cell?

"This report highlights the high prevalence of SCD (8%) in an urban population which may be due to lack of prenatal screening. This high prevalence suggests that the prevalence is under-reported in this area." - Anonymous Online Contributor

Unverified Answer

Can anemia, sickle cell be cured?

"Results from a recent clinical trial of this controlled trial indicate that iron chelation therapy for sickle cell anemia improves hemoglobin and decreases red cell losses." - Anonymous Online Contributor

Unverified Answer

What causes anemia, sickle cell?

"The cause for anemia, sickle cell, is unknown. However, sickle cell disease is linked to environmental factors, such as dehydration, and genetic factors such as sickle cell trait. Sickle cell disease and sickle cell trait are thought to result from environmental as well as inheritable factors.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for anemia, sickle cell?

"Treatments for sickle cell anemia includes oxygen therapy, blood transfusions, and blood transplants. The exact timing and method of transfusion is dependent on the type of anemia encountered and the number of units of blood required. If less transfusions are necessary, one to two units of whole blood can be given by the use of photopheresis, an inexpensive and effective way of collecting the desired units of platelets. Hematopoietic stem cell transplantation therapy is a new method for sickle cell anemia treatment; however, the potential for complications remains, including transplant rejection and immune reconstitution inflammatory Syndrome (IRIS)." - Anonymous Online Contributor

Unverified Answer

What are the signs of anemia, sickle cell?

"Anemia is a common complication of sickle cell disease and affects more than one-quarter of patients. The pathophysiology of anemia and its clinical significance still remain unclear. This review highlights the important clinical relevance of anemia as well as its relevance and severity in sickle cell disease." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets anemia, sickle cell?

"If you're not a member of the medical community, read this article in your community's newspaper to see how common anemia is. If you are concerned about your children, then read below. It should be a concern to every person in our communities to [have your children screened for anemia and sickle cell disease] if they have unexplained vomiting or dizziness, because both of these are signs of anemia. To [have your children screened for anemia and sickle cell disease] is to find the cause of these problems and to treat them. By doing this, [you've improved the chance] that your children will live a healthier life than they might otherwise." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for anemia, sickle cell?

"Women without other comorbidities will likely be the largest group who benefits from treatment. Men will benefit most dramatically if they are symptomatic, are older, are symptomatic with more pain, and are symptomatic with a hemoglobin of less than 10 and 10-11 g/dL. The best way to identify whom will benefit from treatment is by considering these criteria and talking with a doctor who specializes in treating people with anemia and sickle cell disease." - Anonymous Online Contributor

Unverified Answer

How does losartan work?

"Losartan causes a reduction in hemoglobin concentration regardless of the presence of anemia from sickle cell trait. It has also been shown to relieve the anemia-associated symptoms of mild sickle-cell disease in rats. Both these pharmacodynamic or pharmacokinetic effect of losartan on hemoglobin concentration are responsible for the beneficial effects of losartan on sickle-cell disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in losartan for therapeutic use?

"The long-term use of losartan is associated with an increased risk of mortality and heart failure as compared to atorvastatin. The current findings suggested that losartan has no more advantages to minimize mortality compared to statin." - Anonymous Online Contributor

Unverified Answer

How serious can anemia, sickle cell be?

"All cases must be evaluated. In this type of situation, the possibility of iron deficiency can't be neglected. An erythro-siderophilic anemia with no demonstrable underlying cause is also a factor. Hemoglobin levels, if abnormal, must be taken into consideration. It is difficult to distinguish an iron deficiency anemia from a hemoglobinopathy, although the bone marrow might show a marked increase in iron." - Anonymous Online Contributor

Unverified Answer

Is losartan typically used in combination with any other treatments?

"This review shows that most studies were small, and that the majority of these studies were blinded. Consequently, any definitive conclusions about the effectiveness of losartan alone or in combinations with other treatments or the adverse effects of losartan must await a large randomised controlled trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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