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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: t
View:

• 6 years old or older

• Diagnosis of HbSS or Sbeta0-thalassemia

• Ability to cooperate with and undergo CMR without sedation or anesthesia

• Ability to cooperate with and undergo echocardiogram without sedation or anesthesia

• 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.

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Omar Niss, MD
omar.niss@cchmc.org
(513) 803-7545
Backup
Amanda Pfeiffer
amanda.pfeiffer@cchmc.org
(513) 803-4977
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 24
Treatments
Experimental: Losartan
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.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov