Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression

  • STATUS
    Recruiting
  • End date
    Feb 21, 2023
  • participants needed
    100
  • sponsor
    University of Washington
Updated on 21 March 2022
heart disease
hmg-coa reductase inhibitors

Summary

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.

Details
Condition Rheumatic Heart Disease, Valvular Disease
Treatment Atorvastatin, Placebo
Clinical Study IdentifierNCT04575857
SponsorUniversity of Washington
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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