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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants

  • Clinicaltrials.gov identifier

    NCT04572893

  • Recruitment Status

    Recruiting

  • First Posted

    October 1, 2020

  • Last update posted

    June 16, 2022

Study Description

Brief summary:

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

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 24 participants
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants
  • Actual Study Start Date: August 2020
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: January 2025

Arms and interventions

Arm Intervention/treatment
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 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

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

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04572893 History of Changes
  • Other Study ID Numbers: CV028-005, 2019-003626-24
  • First Posted: October 1, 2020 Key Record Dates
  • 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
  • Additional relevant MeSH terms: Cardiomyopathies
    Cardiomyopathy, Dilated
    Cardiomegaly
    Laminopathies
    Genetic Diseases, Inborn
    Heart Diseases
    Cardiovascular Diseases