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

NCT ID: NCT04572893

Last Updated: 2025-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2024-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Familial Dilated Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MYK-491

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

Group Type EXPERIMENTAL

danicamtiv

Intervention Type DRUG

Myosin activator

Interventions

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danicamtiv

Myosin activator

Intervention Type DRUG

Other Intervention Names

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MYK-491 BMS-986434

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0007

La Jolla, California, United States

Site Status

Local Institution - 0010

Washington D.C., District of Columbia, United States

Site Status

Local Institution - 0009

Tampa, Florida, United States

Site Status

Local Institution - 0002

Chicago, Illinois, United States

Site Status

Local Institution - 0003

Boston, Massachusetts, United States

Site Status

Local Institution - 0005

Rochester, Minnesota, United States

Site Status

Local Institution - 0006

Cleveland, Ohio, United States

Site Status

Local Institution - 0019

Columbus, Ohio, United States

Site Status

Local Institution - 0001

Philadelphia, Pennsylvania, United States

Site Status

Local Institution - 0004

Charleston, South Carolina, United States

Site Status

Local Institution - 0008

Germantown, Tennessee, United States

Site Status

Local Institution - 0018

Austin, Texas, United States

Site Status

Local Institution - 0014

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Local Institution - 0015

Würzburg, , Germany

Site Status

Local Institution - 0012

A Coruña, , Spain

Site Status

Local Institution - 0011

El Palmar, , Spain

Site Status

Local Institution - 0013

Majadahonda, , Spain

Site Status

Local Institution - 0016

London, , United Kingdom

Site Status

Local Institution - 0017

Middlesex, , United Kingdom

Site Status

Countries

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United States Germany Spain United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2019-003626-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV028-005

Identifier Type: -

Identifier Source: org_study_id

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