Using losartan to treat heart issues in sickle cell disease
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.
This study tests if the medication losartan can help improve heart problems in people aged 6 and older with sickle cell disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | Crizanlizumab |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05012631 on ClinicalTrials.gov |
What this trial studies
This pilot phase II study investigates the effects of losartan, an angiotensin II receptor blocker, on patients aged 6 years and older with Sickle Cell Disease (SCD) and diffuse myocardial fibrosis. Over the course of 12 months, 24 participants will be enrolled to assess the safety and efficacy of losartan in reducing extracellular volume fraction (ECV). The study aims to gather clinical pilot data to inform future research and treatment strategies for heart complications associated with SCD.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 years or older diagnosed with HbSS or Sbeta0-thalassemia who are stable on sickle cell disease-modifying therapy.
Not a fit: Patients currently undergoing chronic transfusion therapy or with contraindications to cardiac imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart health and quality of life for patients with Sickle Cell Disease.
How similar studies have performed: While this approach is novel in the context of Sickle Cell Disease, similar studies using losartan for other cardiac conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Omar Niss, MD
- Email: omar.niss@cchmc.org
- Phone: (513) 803-7545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.