A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04766892
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 30, 2021
Status verified
Mar 2025
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mavacamten (MYK-461)

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Local Institution - 0028BirminghamAlabama35249-
Local Institution - 0019PhoenixArizona85016-
Local Institution - 0011TucsonArizona85724-
Local Institution - 0005Los AngelesCalifornia90027-
Local Institution - 0026San FranciscoCalifornia94158-
Local Institution - 0020JacksonvilleFlorida32216-
Local Institution - 0014MiamiFlorida33133-
Local Institution - 0018AtlantaGeorgia30322-
Local Institution - 0004ChicagoIllinois60611-
Local Institution - 0023Hazel CrestIllinois60429-
Local Institution - 0017SlidellLouisiana70458-
Local Institution - 0007Grand RapidsMichigan49503-
Local Institution - 0012New YorkNew York10065-
Local Institution - 0003DurhamNorth Carolina27710-
Local Institution - 0016Oklahoma CityOklahoma73135-
Local Institution - 0001PortlandOregon97239-
Local Institution - 0010PortlandOregon97225-
Local Institution - 0002PhiladelphiaPennsylvania19104-
Local Institution - 0008CharlestonSouth Carolina29425-
Local Institution - 0006Salt Lake CityUtah84112-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Local Institution - 0028· Birmingham, ALLocal Institution - 0019· Phoenix, AZLocal Institution - 0011· Tucson, AZLocal Institution - 0005· Los Angeles, CALocal Institution - 0026· San Francisco, CALocal Institution - 0020· Jacksonville, FL

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