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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MyoKardia, Inc.

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)