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ACTIVE NOT RECRUITING
NCT04575857

Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression

Sponsor: University of Washington

View on ClinicalTrials.gov

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.

Official title: Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-02-08

Completion Date

2040-02

Last Updated

2023-06-05

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin

Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.

DRUG

Placebo

Participants in the control arm will receive a pill packet with placebo x 18 months.

Locations (1)

Manmohan Memorial Medical College & Teaching Hospital.

Kathmandu, Nepal