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 or other causalities.

Official Title

An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Participants With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants or Other Causalities

Keywords

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

Eligibility

You can join if…

Open to people ages 18-80

  • For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN
  • Has adequate acoustic windows for echocardiography
  • Maximum of 3 family members with same variant can be enrolled
  • For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants

You CAN'T join if...

  • Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s)
  • 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
  • St. David's Heart & Vascular PLLC, dba Austin Heart accepting new patients
    Austin Texas 78705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls Investigator Inquiry Form
ID
NCT04572893
Phase
Phase 2 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated