# Role of Statins in Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study for a Randomized Controlled Trial

> **NIH NIH R34** · UNIVERSITY OF WASHINGTON · 2020 · $61,439

## Abstract

PROJECT SUMMARY/ABSTRACT
Rheumatic Heart Disease (RHD), the most common cardiovascular disease in those under 25, remains a
significant public health problem in lower and middle-income countries (LMIC). Currently no proven treatment
exists that prevents or delays the development and progression of cardiac sequelae in patients with RHD.
Despite compelling biologic and observational data that suggests statin use delays progression of valvular
heart disease, to date there has not been a randomized controlled trial to test this hypothesis. If statin therapy
indeed delays progression of cardiac sequelae and improves clinical outcomes in patients with RHD, it will
fundamentally shift RHD management strategies world-wide and importantly impact millions of lives, mostly in
LMIC but also in Western countries. The largely benign safety profile of statins and their wide availability will
further guarantee the usage and scalability of such therapy. We aim to leverage our long-existing
collaborations between colleagues at the University of Washington, Seattle, and institutions in Nepal
(Manmohan Cardiothoracic, Vascular and Transplant Center; Dhulikhel Hospital Kathmandu University
Hospital), an RHD endemic country, to conduct a pilot study to assess feasibility and gain implementation
insights for conducting a larger RCT that will evaluate safety and efficacy of atorvastatin among RHD patients.
The goal of this R34 application is to address specific implementation questions necessary and
sufficient to ensure the feasibility of the larger RCT. With this study, we will build a registry of RHD patients
in order to facilitate research on RHD subjects. We will then pilot a small feasibility study, administering low
dose atorvastatin or placebo in a double blind randomized controlled fashion to 100 adult RHD patients,
obtaining echocardiograms at baseline and end of study in 18 months, and following patients for RHD-related
cardiovascular events. The feasibility study will address the following aims: (1) understand the recruitment,
adherence, and retention rates and (2) evaluate the rate of valvular disease progression, and secondarily,
composite cardiovascular endpoints in this population. The answers to the above questions are both necessary
and sufficient to effectively design a larger trial to test the efficacy of statins in mitigating valvular damage.

## Key facts

- **NIH application ID:** 9962484
- **Project number:** 5R34HL143279-03
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Nona Sotoodehnia
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $61,439
- **Award type:** 5
- **Project period:** 2018-08-15 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9962484

## Citation

> US National Institutes of Health, RePORTER application 9962484, Role of Statins in Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study for a Randomized Controlled Trial (5R34HL143279-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9962484. Licensed CC0.

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