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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Primary Familial Dilated Cardiomyopathy

Treatments: Drug: danicamtiv

Study type: Interventional

Funder types: Industry

Identifiers

NCT04572893

2019-003626-24 (EudraCT Number)

CV028-005

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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41 participants in 1 patient group

MYK-491

Experimental group

Description:

Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants

Treatment:

Drug: danicamtiv