Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-16 @ 6:41 AM
Study NCT ID:
NCT04575857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2020-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R34HL143279 | NIH | None | https://reporter.nih.gov/quic… | View |