Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial

STUDY00008837

The goal of this study is to address specific implementation questions necessary and sufficient to ensure the feasibility of the larger randomized trial examining the efficacy of statin medications in slowing rheumatic heart disease (RHD) valvular pathology progression. This feasibility study is intended to confirm the number of readily recruitable subjects, assess recruitment rate, and assess the rate of valve pathology via echocardiograms. These results are necessary and sufficient to facilitate the successful design of a large full scale randomized trial to determine whether statins improve outcomes in RHD. Successful treatment of RHD would fundamentally shift the RHD management paradigm world-wide, improve the lives of millions afflicted with RHD, and subsequently, decrease health care spending on RHD management.

2022-02-08

2040-02-01

2040-02-01

Active (not recruiting)

100

Inclusion Criteria: * ≥ 18 years * History of RHD as evidenced by at least one echocardiographic examination * No history of cardiac surgery Exclusion Criteria: * ≥ 75 or \< 18 years old * Absence of RHD or RF history * Active liver disease * Impaired hepatic and renal function, including unexplained elevated levels of alanine transaminase greater than twice the upper limit of normal * History of previous statin intolerance or muscle disorders * Current pregnancy (by history or lab assessment of beta hCG) or plans for pregnancy in the next 18 months). Current lactation / breast feeding. * LDL \<60

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-06-05