NCT04575857

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatic Heart Disease
• Valvular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-08
• Primary completion: 2040-02-01
• Completion: 2040-02-01
• First posted: 2020-10-05
• Last updated: 2023-06-05

Locations

1 site across 1 country: Nepal