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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-08

Study Completion Date

2040-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatic Heart Disease Valvular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Statin arm

To receive pill packet with atorvastatin (40mg/day) which will be taken nightly.

Atorvastatin

Intervention Type DRUG

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

Placebo arm

To receive pill packet with placebo which will be taken nightly

Placebo

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Statin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No