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| Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants |
| Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
| NCT04572893 | Recruiting | October 1, 2020 | June 16, 2022 |
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| study description |
| Brief Summary |
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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. |
| Condition or Disease: | Primary Familial Dilated Cardiomyopathy |
| Intervention/treatment: | Drug: danicamtiv |
| Phase: | Phase 2 |
| Detailed Description |
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N/A |
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| study design | ||||||||||||||||||||
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| Arms and interventions |
| Arm | Intervention/treatment |
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Experimental: MYK-491 Primary DCM due to MYH7 or TTN Variant |
Drug: danicamtiv Myosin activator |
| outcome measures |
| Primary Outcome Measures: |
1. Frequency and severity of treatment-emergent adverse events and serious adverse events. [ Time Frame: Up to 22 days, optional extension of up to 96 weeks ] |
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| Eligibility Criteria |
| Ages Eligible for Study: | 18 to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Criteria |
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Inclusion Criteria: Has stable primary dilated cardiomyopathy due to either MYH7 or TTN variant Has adequate acoustic windows for echocardiography Maximum of 3 family members with same variant can be enrolled Exclusion Criteria: Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s) A pathogenic variant implicated in DCM of another gene other than MYH7 or TTN Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics) Presence of protocol specified laboratory abnormalities at Screening Recent acute coronary syndrome or angina pectoris (<90 days) Recent hospitalization for heart failure (<90 days) |
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| Contacts and Locations |
| Contacts |
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Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com 855-907-3286 clinical.trials@bms.com Contact: First line of the email MUST contain NCT # and Site #. |
| Locations |
| United States, California | University Of California - San Diego Medical Center | La Jolla |
| United States, District of Columbia | MedStar Georgetown University Hospital | Washington |
| United States, Florida | University of South Florida | Tampa |
| United States, Illinois | Local Institution | Chicago |
| United States, Massachusetts | Brigham And Women'S Hospital | Boston |
| United States, Minnesota | Local Institution | Rochester |
| United States, Ohio | Cleveland Clinic | Cleveland |
| United States, Pennsylvania | University of Pennsylvania | Philadelphia |
| United States, South Carolina | Medical University of South Carolina | Charleston |
| United States, Tennessee | Stern Cardiovascular Foundation Inc | Germantown |
| United States, Texas | St. David's Heart & Vascular PLLC, dba Austin Heart | Austin |
| Germany | Local Institution | Heidelberg |
| Germany | Universitaetsklinikum Wuerzburg-Department of Dermatology | Wuerzburg |
| Spain | Local Institution - 0012 | A Coruña |
| Spain | Local Institution | El Palmar |
| Spain | Local Institution | Majadahonda |
| United Kingdom | Local Institution | London |
| United Kingdom | Local Institution | Middlesex |
| Sponsors and Collaborators |
| Bristol-Myers Squibb |
| Investigator | ||
| Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
| More Information | ||||||||||
| Responsible Party : | Bristol-Myers Squibb | |||||||||
| ClinicalTrials.gov Identifier : | NCT04572893 | |||||||||
| Other Study ID Numbers : | CV028-005, 2019-003626-24 | |||||||||
| First Posted : | October 1, 2020 | |||||||||
| Last Update Posted : | June 16, 2022 | |||||||||
| Last Verified : | June 2022 | |||||||||
| Studies a U.S. FDA-regulated Drug Product: | Yes | |||||||||
| Studies a U.S. FDA-regulated Device Product: | No | |||||||||
| Keywords provided by Bristol-Myers Squibb: |
Primary dilated cardiomyopathy (DCM) Familial dilated cardiomyopathy (DCM) Myosin Heavy Chain 7 (MYH7) Titin (TTN) MYK-491 danicamtiv |
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| Additional relevant MeSH terms : |
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