Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    24
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 26 January 2022
Accepts healthy volunteers

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.

Details
Condition Sickle Cell Disease, Diffuse Myocardial Fibrosis
Treatment losartan
Clinical Study IdentifierNCT05012631
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Any contraindication to CMR such as metallic implants
Inability to cooperate with CMR or echocardiography imaging
Known congenital heart disease
Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance
Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study
Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment
Hypersensitivity to angiotensin receptor II blockers
Hyperkalemia (K>5.5 mEq/L) on a non-hemolyzed sample despite low-potassium diet
Hepatic dysfunction defined as serum ALT > 5x the upper normal limit for age
Current lithium therapy
Chronic daily use of NSAID
HIV infection

Exclusion Criteria

Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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