Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
Megadott ok: Business objectives have changed
A legfontosabb adatok
- Hol
- Austin, Boston, Charleston, Chicago, Cleveland, Columbus, Germantown, La Jolla, Philadelphia, Rochester, Tampa és Washington D.C. (Egyesült Államok)Mind a 12 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- 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
A vizsgálat adatai
- Ki végzi
- Bristol-Myers Squibb
- Azonosító
- NCT04572893EU 2023-505492-68-00
- A regiszteradat frissítve
- 2025. május 21.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.