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.
Study Type
OBSERVATIONAL
Enrollment
100
Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
Participants in the control arm will receive a pill packet with placebo x 18 months.
Manmohan Memorial Medical College & Teaching Hospital.
Kathmandu, Nepal
Enrollment rate
Defined as the proportion of approached eligible participants who consent to enroll in the study
Time frame: Measured at study enrollment
Medication adherence
The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken
Time frame: Measured at month 1
Medication adherence
The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken
Time frame: Measured at months 6
Medication adherence
The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken
Time frame: Measured at months 12
Medication adherence
The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken
Time frame: Measured at months 18
Retention rate
Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion
Time frame: Measured at Month 18
Rate of progression of valvular disease
Compare month 18 echocardiogram with baseline echocardiogram
Time frame: Change between baseline and Month 18
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