Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT05012631|
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : December 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Diffuse Myocardial Fibrosis||Drug: Losartan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease: A Prospective, Phase II Study.|
|Actual Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
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.
Losartan dosing for participants <16 years will be 0.7 mg/kg (maximum of 50 mg) once daily. The dose can be increased to 1.4 mg/kg (maximum of 100 mg once daily) after 2 weeks if the dose was tolerated (no hypotension or hyperkalemia). For patients ≥16 years, the starting dose will be 50 mg once daily which can be increased to 100 mg daily if tolerated after 2 weeks.
- Change in extracellular volume fraction (ECV) after 1 year of losartan treatment [ Time Frame: after 1 year of losartan treatment. ]Efficacy of losartan in stabilizing or reducing ECV (diffuse myocardial fibrosis) in SCD after one year.
- Change in Diastolic Function [ Time Frame: after 1 year of losartan treatment. ]Efficacy of losartan in improving diastolic function defined by echocardiographic and tissue Doppler assessment .
- Change in Exercise Capacity [ Time Frame: after 1 year of losartan treatment. ]Efficacy of losartan in improving cardiopulmonary exercise testing (CPET) measurements.
- Predicting Myocardial Fibrosis [ Time Frame: At baseline and after one year of losartan treaement ]Explore the performance characteristics of the following serum biomarkers in predicting myocardial fibrosis in patients with SCD: PICP, PIIINP, TGF-β, CTGF, soluble ST2, galectin-3, and NT-proBNP.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05012631
|Contact: Omar Niss, MD||(513) firstname.lastname@example.org|
|Contact: Amanda Pfeiffer||(513) email@example.com|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Amanda Pfeiffer 513-803-4977 Amanda.Pfeiffer@cchmc.org|
|Contact: Amy Shova (513)803-1917 Amy.Shova@cchmc.org|
|Principal Investigator: Omar Niss, MD|