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

NCT04575857 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-06-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Manmohan Cardiothoracic Vascular and Transplant Center

    collaborator UNKNOWN

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Nona Sotoodehnia, MD, MPH · University of Washington

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2040-02-29
Completion
2040-02-29

Countries

  • Nepal

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575857 on ClinicalTrials.gov