Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
Reason given: Business objectives have changed
Key facts
- Where
- Austin, Boston, Charleston, Chicago, Cleveland, Columbus, Germantown, La Jolla, Philadelphia, Rochester, Tampa, and Washington D.C., United StatesSee the 12 sites
- Phase
- Phase 2
Where in United States
- Austin, TexasHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Charleston, South CarolinaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Columbus, OhioHospital not named in the registryNo longer taking part
- Germantown, TennesseeHospital not named in the registryNo longer taking part
- La Jolla, CaliforniaHospital not named in the registryNo longer taking part
- Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
- Rochester, MinnesotaHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT04572893EU 2023-505492-68-00
- Record updated
- 21 May 2025
- Original description
The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.Read full original descriptionShow less
An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Participants With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants or Other Causalities
The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.
Inclusion: For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN; Has adequate acoustic windows for echocardiography; Maximum of 3 family members with same variant can be enrolled; For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants.
Exclusion: Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s); Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics); Recent acute coronary syndrome or angina pectoris (<90 days); Recent hospitalization for heart failure (<90 days); Presence of protocol specified laboratory abnormalities at Screening.