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

About the study

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.

Study point of contact

Amanda Pfeiffer
(513) 803-4977
[email protected]
Omar Niss, MD
(513) 803-7545
[email protected]

Locations

1 United States site

Age

> 6 Years

Genotypes

HbSS

Phase

Phase 2

Study type

Interventional

Age

6 Years -

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

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.

participation restrictions

Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
SCD genotypes other than specified in

Locations

  • Cincinnati, Ohio, United States, Cincinnati Children's Hospital Medical Center, 45229 [Recruiting]
Last updated 2021-12-07