RECRUITING

Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease

Conditions

Sickle Cell Disease Diffuse Myocardial Fibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a pilot, phase II, open-label study of the angiotensin II receptor blocker, losartan, in patients with Sickle Cell Disease (SCD) 6 years or older for 12 months. The investigators will enroll 24 patients with SCD over the course of 1 year with a goal to complete all study procedures in 2 years. The short-term goal is to obtain clinical pilot data regarding the safety and efficacy of losartan in stabilizing or decreasing extracellular volume fraction (ECV) after 12 months of therapy.

Official Title

Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.

Quick Facts

Study Start:2021-09-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05012631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 6 years old or older 2. Diagnosis of HbSS or Sbeta0-thalassemia 3. Ability to cooperate with and undergo CMR without sedation or anesthesia 4. Ability to cooperate with and undergo echocardiogram without sedation or anesthesia 5. Patients who are on a stable dose of sickle cell disease-modifying therapy: Hydroxyurea, Voxelotor, L-Glutamine, or Crizanlizumab, for 3 months prior to enrollment will be eligible.	1. Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion 2. SCD genotypes other than specified in inclusion criteria 3. Any contraindication to CMR such as metallic implants 4. Inability to cooperate with CMR or echocardiography imaging 5. Known congenital heart disease 6. Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance 7. Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study 8. Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment 9. Hypersensitivity to angiotensin receptor II blockers 10. Hyperkalemia (K\>5.5 mEq/L) on a non-hemolyzed sample despite low-potassium diet 11. Hepatic dysfunction defined as serum ALT \> 5x the upper normal limit for age 12. Current lithium therapy 13. Chronic daily use of NSAID 14. HIV infection.

Inclusion Criteria

Exclusion Criteria

1. 6 years old or older
2. Diagnosis of HbSS or Sbeta0-thalassemia
3. Ability to cooperate with and undergo CMR without sedation or anesthesia
4. Ability to cooperate with and undergo echocardiogram without sedation or anesthesia
5. Patients who are on a stable dose of sickle cell disease-modifying therapy: Hydroxyurea, Voxelotor, L-Glutamine, or Crizanlizumab, for 3 months prior to enrollment will be eligible.

1. Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
2. SCD genotypes other than specified in inclusion criteria
3. Any contraindication to CMR such as metallic implants
4. Inability to cooperate with CMR or echocardiography imaging
5. Known congenital heart disease
6. Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance
7. Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study
8. Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment
9. Hypersensitivity to angiotensin receptor II blockers
10. Hyperkalemia (K\>5.5 mEq/L) on a non-hemolyzed sample despite low-potassium diet
11. Hepatic dysfunction defined as serum ALT \> 5x the upper normal limit for age
12. Current lithium therapy
13. Chronic daily use of NSAID
14. HIV infection.

Contacts and Locations

Study Contact

Omar Niss, MD

CONTACT

(513) 803-7545

omar.niss@cchmc.org

Amanda Pfeiffer

CONTACT

(513) 803-4977

amanda.pfeiffer@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-09-01

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Sickle Cell Disease
Diffuse Myocardial Fibrosis