Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
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About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
100 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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