Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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 .

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

Keywords

Primary Familial Dilated Cardiomyopathy Primary dilated cardiomyopathy (DCM) Familial dilated cardiomyopathy (DCM) Myosin Heavy Chain 7 (MYH7) Titin (TTN) MYK-491 danicamtiv Cardiomyopathies Cardiomyopathy, Dilated

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California, San Diego Medical Center accepting new patients
    La Jolla California 92037 United States
  • Austin Heart accepting new patients
    Austin Texas 78666 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MyoKardia, Inc.
ID
NCT04572893
Phase
Phase 2
Study Type
Interventional
Last Updated