Rheumatic Heart Disease Clinical Trial
Official title:
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial
Verified date | June 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | February 2040 |
Est. primary completion date | February 2040 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Nepal | Manmohan Memorial Medical College & Teaching Hospital. | Kathmandu |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Manmohan Cardiothoracic Vascular and Transplant Center, National Heart, Lung, and Blood Institute (NHLBI) |
Nepal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrollment rate | Defined as the proportion of approached eligible participants who consent to enroll in the study | Measured at study enrollment | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Retention rate | Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion | Measured at Month 18 | |
Primary | Rate of progression of valvular disease | Compare month 18 echocardiogram with baseline echocardiogram | Change between baseline and Month 18 |
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