Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Statin arm To receive pill packet with atorvastatin (40mg/day) which will be taken nightly. |
Drug: Atorvastatin
Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
Other Names:
|
| Placebo arm To receive pill packet with placebo which will be taken nightly |
Drug: Placebo
Participants in the control arm will receive a pill packet with placebo x 18 months.
|
Outcome Measures
Primary Outcome Measures
- 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
- Medication adherence [Measured at months 6]
The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken
- Medication adherence [Measured at months 12]
The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken
- Medication adherence [Measured at months 18]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥ 18 years
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History of RHD as evidenced by at least one echocardiographic examination
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No history of cardiac surgery
Exclusion Criteria:
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≥ 75 or < 18 years old
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Absence of RHD or RF history
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Active liver disease
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Impaired hepatic and renal function, including unexplained elevated levels of alanine transaminase greater than twice the upper limit of normal
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History of previous statin intolerance or muscle disorders
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Current pregnancy (by history or lab assessment of beta hCG) or plans for pregnancy in the next 18 months). Current lactation / breast feeding.
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LDL <60
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Manmohan Memorial Medical College & Teaching Hospital. | Kathmandu | Nepal |
Sponsors and Collaborators
- University of Washington
- Manmohan Cardiothoracic Vascular and Transplant Center
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Nona Sotoodehnia, MD, MPH, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00008837
- 5R34HL143279