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 TROPONIN I AND/OR NT-PROBNP
Recruiting
99 years or below
All
Phase
2
5 participants needed
1 Location
Brief description of study
This is a multicenter, exploratory, open-label study to explore the efficacy and/or pharmacodynamic effect, PK, safety, and tolerability of mavacamten in approximately 35 ambulatory participants with symptomatic HFpEF and elevated cTnI and/or elevated NT-proBNP as defined in inclusion/exclusion criteria. The study will include an up to 7-week screening period (with an initial biomarker prescreen that may be performed remotely via home health nurse), a 26-week treatment period, and an 8-week posttreatment follow-up period.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
-
Gender: All
Updated on
04 Feb 2021.
Study ID: 844558