Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Enrollment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •History of RHD as evidenced by at least one echocardiographic examination
- •No history of cardiac surgery
排除标准
- •≥ 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.
研究组 & 干预措施
Statin arm
To receive pill packet with atorvastatin (40mg/day) which will be taken nightly.
干预措施: Atorvastatin (Drug)
Placebo arm
To receive pill packet with placebo which will be taken nightly
干预措施: Placebo (Drug)
结局指标
主要结局
Enrollment rate
时间窗: Measured at study enrollment
Defined as the proportion of approached eligible participants who consent to enroll in the study
Retention rate
时间窗: Measured at Month 18
Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion
Medication adherence
时间窗: 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
Rate of progression of valvular disease
时间窗: Change between baseline and Month 18
Compare month 18 echocardiogram with baseline echocardiogram
次要结局
未报告次要终点
研究者
Nona Sotoodehnia
Co-Director, Cardiovascular Health Research Unit
University of Washington