Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766892
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2021-02-16
Brief Title:
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
An Exploratory Open-label Proof-of-concept Phase 2a Study of Mavacamten MYK-461 in Participants With Heart Failure With Preserved Ejection Fraction HFpEF and Chronic Elevation of Cardiac Biomarkers
Status:
COMPLETED
Status Verified Date:
2024-08
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:
EMBARK-HFpEF
Brief Summary:
This is a Phase 2a proof-of-concept study to assess safety tolerability and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction HFpEF and elevation of NT-proBNP with or without elevation of cTnT Data from this study will inform future study designs of mavacamten in patients with HFpEF
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None