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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04575857
Other study ID # STUDY00008837
Secondary ID 5R34HL143279
Status Active, not recruiting
Phase
First received
Last updated
Start date February 8, 2022
Est. completion date February 2040

Study information

Verified date June 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Atorvastatin
Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
Placebo
Participants in the control arm will receive a pill packet with placebo x 18 months.

Locations

Country Name City State
Nepal Manmohan Memorial Medical College & Teaching Hospital. Kathmandu

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Manmohan Cardiothoracic Vascular and Transplant Center, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Nepal, 

Outcome

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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