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

Active, not recruiting

• Conditions: Valvular Disease; Rheumatic Heart Disease
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT04575857
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-05
• Study Start: 2022-02-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05
• Primary Completion: 2040-02
• Study Completion: 2040-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	To receive pill packet with placebo which will be taken nightly
Statin arm	Atorvastatin	To receive pill packet with atorvastatin (40mg/day) which will be taken nightly.

Primary Outcome Measures

Name	Time	Method
Enrollment rate	Measured at study enrollment	Defined as the proportion of approached eligible participants who consent to enroll in the study
Retention rate	Measured at Month 18	Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion
Medication adherence	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	Change between baseline and Month 18	Compare month 18 echocardiogram with baseline echocardiogram

Trial Locations

Locations (1)

Manmohan Memorial Medical College & Teaching Hospital.; 🇳🇵 Kathmandu, Nepal