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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatic Heart Disease, Valvular Disease

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Statin arm<br>To receive pill packet with atorvastatin (40mg/day) which will be taken nightly. | Drug: Atorvastatin<br>* Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.<br>* Other names: Statin;|
| Placebo arm<br>To receive pill packet with placebo which will be taken nightly | Drug: Placebo<br>* Participants in the control arm will receive a pill packet with placebo x 18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate | Defined as the proportion of approached eligible participants who consent to enroll in the study | 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 | 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 | 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 | 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 | Measured at months 18 | 
| Retention rate | Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion | Measured at Month 18 | 
| Rate of progression of valvular disease | Compare month 18 echocardiogram with baseline echocardiogram | Change between baseline and Month 18 |