Rheumatic Heart Disease, Valvular Disease
Conditions
Brief 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.
Interventions
DRUGAtorvastatin
Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
DRUGPlacebo
Participants in the control arm will receive a pill packet with placebo x 18 months.
Sponsors
Manmohan Cardiothoracic Vascular and Transplant Center
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Measured at study enrollment | Defined as the proportion of approached eligible participants who consent to enroll in the study |
| Medication adherence | Measured at month 1 | The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken |
| Retention rate | Measured at Month 18 | Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion |
| Rate of progression of valvular disease | Change between baseline and Month 18 | Compare month 18 echocardiogram with baseline echocardiogram |
Countries
Nepal
Outcome results
None listed