This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

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.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

    October 15, 2021

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: An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants
  • Actual Study Start Date: August 2020
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: September 2023

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 Medical Information (Use email contact) clinical.trials@bms.com

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
Medical Center of Northwestern University
Chicago

United States, Massachusetts
Brigham and Women's Hospital
Boston

United States, Minnesota
Mayo Clinic - Rochester
Rochester

United States, Ohio
Cleveland Clinic
Cleveland

United States, Ohio
Ohio State University Wexner Medical Center
Columbus

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

United States, South Carolina
Medical University of South Carolina
Charleston

United States, Tennessee
The Stern Cardiovascular Center
Germantown

United States, Texas
Austin Heart
Austin

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Germany
Universitaetsklinikum Würzburg
Würzburg

Spain, Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda

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

Spain
Complejo Hospitalario Universitario A Coruña
A Coruña

United Kingdom
St. Bartholomew's Hospital
London

United Kingdom
Royal Brompton Hospital
London

Sponsors and Collaborators

MyoKardia, Inc.

More Information

  • Responsible Party: MyoKardia, Inc.
  • ClinicalTrials.gov 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: October 15, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by MyoKardia, Inc.: danicamtiv
    MYK-491
    Titin (TTN)
    Myosin Heavy Chain 7 (MYH7)
    Familial dilated cardiomyopathy (DCM)
    Primary dilated cardiomyopathy (DCM)
  • Additional relevant MeSH terms: Cardiomyopathy, Dilated Cardiomyopathies