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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 1 year of losartan treatment.
Awards & highlights
Study Summary
This trial is testing if losartan, a drug used to treat high blood pressure, is safe and effective in treating sickle cell disease in people 6 years and older.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 6 years old or older.
Select...
I have been diagnosed with HbSS or Sbeta0-thalassemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 1 year of losartan treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 1 year of losartan treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in extracellular volume fraction (ECV) after 1 year of losartan treatment
Secondary outcome measures
Change in Diastolic Function
Change in Exercise Capacity
Predicting Myocardial Fibrosis
Side effects data
From 2021 Phase 4 trial • 227 Patients • NCT0218812143%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual 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
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,567 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My sickle cell disease genotype is not listed in the study's accepted types.You are allergic to angiotensin receptor II blockers.I am on ongoing blood transfusion therapy.I am not pregnant or breastfeeding and can use birth control during the study.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.You have metal implants that could interfere with a special type of imaging called CMR.My kidney function is low, with a GFR of 30 mL/min/1.73 m^2 or less.I was born with a heart condition.I have been treated with a renin-angiotensin inhibitor in the last 2 weeks.I am HIV positive.I am currently taking lithium.My liver enzyme ALT levels are more than five times the normal limit.I am 6 years old or older.I have been diagnosed with HbSS or Sbeta0-thalassemia.I use NSAID pain relievers every day.
Research Study Groups:
This trial has the following groups:- Group 1: Losartan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the United States' Food and Drug Administration given clearance to Losartan?
"Losartan's safety is supported by some data, but not to the same extent as a Phase 3 medication. Our team at Power rated it a 2."
Answered by AI
What medical conditions does Losartan usually help to improve?
"Losartan is most commonly used as an intervention for diabetic nephropathy. It can also be administered to treat a variety of other conditions including left ventricular hypertrophy, proteinuria, hypertensive disease."
Answered by AI
What is the population size of this clinical trial?
"That is correct. As seen on clinicaltrials.gov, this study is still recruiting patients that meet the eligibility criteria. The trial was first posted on September 1st, 2021 and was last updated December 7th, 2021. In total, the study needs 24 participants from 1 site."
Answered by AI
Can you provide more information on other research projects that have included Losartan?
"Currently, 30 different clinical trials are investigating Losartan's efficacy. Out of these 30 studies, 2 have reached Phase 3. Notably, several of the trials for Losartan are taking place in San Francisco but there are 532 locations running clinical trials for Losartan nationwide."
Answered by AI
Are investigators presently looking for new participants for this research?
"The trial, which was updated on December 7th 2021 and originally posted September 1st 2021 according to clinicaltrials.gov, is currently recruiting patients."
Answered by AI
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