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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04572893

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Primary Familial Dilated Cardiomyopathy	Drug: danicamtiv	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

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 :

Aug 4, 2020

Anticipated Primary Completion Date :

Dec 5, 2022

Anticipated Study Completion Date :

Jan 3, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MYK-491 Primary DCM due to MYH7 or TTN Variant	Drug: danicamtiv Myosin activator Other Names: MYK-491

Arm

Intervention/Treatment

Experimental: MYK-491

Primary DCM due to MYH7 or TTN Variant

Drug: danicamtiv

Myosin activator

Other Names:

MYK-491

Outcome Measures

Primary Outcome Measures

Frequency and severity of treatment-emergent adverse events and serious adverse events. [Up to 22 days, optional extension of up to 96 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Of California - San Diego Medical Center	La Jolla	California	United States	92037
2	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
3	University of South Florida	Tampa	Florida	United States	33606
4	Local Institution	Chicago	Illinois	United States	60611-5966
5	Brigham And Women'S Hospital	Boston	Massachusetts	United States	02115
6	Local Institution	Rochester	Minnesota	United States	55905
7	Cleveland Clinic	Cleveland	Ohio	United States	44195
8	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
9	Medical University of South Carolina	Charleston	South Carolina	United States	29425
10	Stern Cardiovascular Foundation Inc	Germantown	Tennessee	United States	38138
11	St. David's Heart & Vascular PLLC, dba Austin Heart	Austin	Texas	United States	78705
12	Local Institution	Heidelberg		Germany	69120
13	Universitaetsklinikum Wuerzburg-Department of Dermatology	Wuerzburg		Germany	97080
14	Local Institution - 0012	A Coruña		Spain	15006
15	Local Institution	El Palmar		Spain	30120
16	Local Institution	Majadahonda		Spain	28222
17	Local Institution	London		United Kingdom	EC1A 7BE
18	Local Institution	Middlesex		United Kingdom	UB9 6JH