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

  • identifier


  • Recruitment Status


  • First Posted

    October 1, 2020

  • Last update posted

    April 22, 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


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


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


Contact: BMS Medical Information (Use email contact)


United States, California
University of California, San Diego Medical Center
La Jolla

United States, District of Columbia
MedStar Georgetown University Hospital

United States, Florida
University of South Florida

United States, Illinois
Northwestern Medical Faculty Foundation

United States, Massachusetts
Brigham and Women's Hospital

United States, Minnesota
Mayo Clinic - Rochester

United States, Ohio
Cleveland Clinic

United States, Ohio
Ohio State University Medical Center

United States, Pennsylvania
University of Pennsylvania - Heart and Vascular Center

United States, South Carolina
Medical University of South Carolina

United States, Tennessee
The Stern Cardiovascular Center

United States, Texas
Austin Heart

Universitaetsklinikum Heidelberg

Universitaetsklinikum Würzburg

Spain, Madrid
Hospital Universitario Puerta de Hierro Majadahonda

Spain, Murcia
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar

Complejo Hospitalario Universitario A Coruña
A Coruña

United Kingdom
St. Bartholomew's Hospital

United Kingdom
Royal Brompton Hospital

Sponsors and Collaborators

MyoKardia, Inc.

More Information

  • Responsible Party: MyoKardia, Inc.
  • Identifier: NCT04572893 History of Changes
  • Other Study ID Numbers: MYK-491-006, 2019-003626-24
  • First Posted: October 1, 2020 Key Record Dates
  • Last Update Posted: April 22, 2022
  • Last Verified: December 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by MyoKardia, Inc.: Primary dilated cardiomyopathy (DCM)
    Familial dilated cardiomyopathy (DCM)
    Myosin Heavy Chain 7 (MYH7)
    Titin (TTN)
  • Additional relevant MeSH terms: Cardiomyopathies
    Cardiomyopathy, Dilated
    Heart Diseases
    Cardiovascular Diseases
    Genetic Diseases, Inborn