Primary Familial Dilated CardiomyopathyPhase 2NCT04572893

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

A Phase 2 study testing danicamtiv in people with Primary Familial Dilated Cardiomyopathy, run by Bristol-Myers Squibb at 19 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Primary Familial Dilated Cardiomyopathy
What is being tested?: danicamtiv
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 19 sitesin 4 countries
Study dates: 4 Aug 2020to 22 Feb 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

19 sites in 4 countries.

Country

City, postcode or hospital

19 sites in 4 countries

United States12 sites

Local Institution - 0018
Austin, Texas, 78705
Local Institution - 0003
Boston, Massachusetts, 02115
Local Institution - 0004
Charleston, South Carolina, 29425
Local Institution - 0002
Chicago, Illinois, 60611-5966
Local Institution - 0006
Cleveland, Ohio, 44195-0001
Local Institution - 0019
Columbus, Ohio, 43210
Local Institution - 0008
Germantown, Tennessee, 38138
Local Institution - 0007
La Jolla, California, 92037
Local Institution - 0001
Philadelphia, Pennsylvania, 19104
Local Institution - 0005
Rochester, Minnesota, 55905
Local Institution - 0009
Tampa, Florida, 33612
Local Institution - 0010
Washington D.C., District of Columbia, 20007

Other trials in United States

Spain3 sites

Local Institution - 0012
A Coruña, 15006
Local Institution - 0011
El Palmar, 30120
Local Institution - 0013
Majadahonda, 28222

Other trials in Spain

Germany2 sites

Local Institution - 0014
Heidelberg, Baden-Wurttemberg, 69120
Local Institution - 0015
Würzburg, 97080

Other trials in Germany

United Kingdom2 sites

Local Institution - 0016
London, EC1A 7BE
Local Institution - 0017
Middlesex, UB9 6JH

Other trials in United Kingdom

About this study

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

Conditions: Primary Familial Dilated Cardiomyopathy
Being tested: danicamtiv
Keywords: Primary dilated cardiomyopathy (DCM), Familial dilated cardiomyopathy (DCM), Myosin Heavy Chain 7 (MYH7), Titin (TTN), MYK-491, danicamtiv
Medical subject headings: Campomelic Dysplasia, Cardiomyopathy, Dilated, familial dilated cardiomyopathy, Distal Myopathies, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

danicamtivDrug
Also called MYK-491, BMS-986434
Myosin activator

Study groups in NCT04572893
Study group	Role	What they receive
MYK-491	Experimental	Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants Receives: Drug: danicamtiv

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) in Part A
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Serious Adverse Events (SAEs) in Part A
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.
Measured: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Safety Laboratory Assessments by Intensity in Part A
Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.
Measured: From first dose to 14 days post last dose (Up to approximately 13 weeks)
Number of Participants With Clinically Significant Changes in Physical Examinations in Part A
Number of participants with clinically significant changes in physical examinations.
Measured: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Clinically Significant Changes in Vital Signs in Part A
Number of participants with clinically significant changes in vital signs.
Measured: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A
Number of participants with clinically significant changes in 12-lead ECG recordings.
Measured: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.
Severe= An event preventing normal everyday activities. (An AE that is assessed as severe should not be confused with a SAE. Severe is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.)
Measured: From first dose to 14 days post last dose (Up to approximately 13 weeks)

Secondary outcomes (21)

Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. Higher LAFI values are considered better left atrial function while lower LFAI values may indicate left atrial dysfunction.
Measured: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202022 Feb 2024

First posted1 Oct 2020
Study start4 Aug 2020
Primary completion22 Feb 2024
Study completion22 Feb 2024

Why it stopped: Business objectives have changed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Familial Dilated CardiomyopathyStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04572893
Sponsor's protocol ID: CV028-005
Other IDs: 2019-003626-24, 2019
Status last verified: May 2025
First submitted: 9 Sep 2020
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Lakdawala NK, Hershberger RE, Garcia-Pavia P, Elliott PM, Ginns J, Meder B, Solomon S, Cunningham JW, Gimeno JR, Barriales-Villa R, Adler E, Gerull B, Pereira NL, Halliday BP, Li W, Jarugula P, Maruyama S, Mohran SE, Papadaki M, Anto AR, Anderson RL, Rodriguez HM, Del Rio CL, Edelberg JM, Kurio G, Maya J, Januzzi JL. Danicamtiv, a Selective Agonist of Cardiac Myosin, for Dilated Cardiomyopathy: A Phase 2 Open-Label Trial. J Am Coll Cardiol. 2025 Dec 23;86(25):2598-2612. doi: 10.1016/j.jacc.2025.09.1511. Epub 2025 Sep 29.
PubMed 41217321

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Study of the Progression of Chronic Cardiovascular Conditions
Cardiovascular Disease (CVD), Heart Failure
RecruitingObservational study
Mayo AVC Registry and Biobank
Arrhythmogenic Right Ventricular Cardiomyopathy, Cardiomyopathies

All Primary Familial Dilated Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04572893
Acronym / sponsor ID: CV028-005
Conditions: Primary Familial Dilated Cardiomyopathy
Keywords: Primary dilated cardiomyopathy (DCM), Familial dilated cardiomyopathy (DCM), Myosin Heavy Chain 7 (MYH7), Titin (TTN), MYK-491, danicamtiv
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business objectives have changed
Enrolment: 41 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 4 Aug 2020 (actual)
Primary completion: 22 Feb 2024 (actual)
Study completion: 22 Feb 2024 (actual)
First posted: 1 Oct 2020 (actual)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MYK-491	Experimental	Drug: danicamtivPrimary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
danicamtivAlso: MYK-491, BMS-986434Myosin activator	Drug	MYK-491

Primary outcome

Number of Participants With Adverse Events (AEs) in Part A
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Number of Participants With Serious Adverse Events (SAEs) in Part A
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.
Number of Participants With Safety Laboratory Assessments by Intensity in Part A
Time frame: From first dose to 14 days post last dose (Up to approximately 13 weeks)
Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.
Number of Participants With Clinically Significant Changes in Physical Examinations in Part A
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of participants with clinically significant changes in physical examinations.
Number of Participants With Clinically Significant Changes in Vital Signs in Part A
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of participants with clinically significant changes in vital signs.
Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of participants with clinically significant changes in 12-lead ECG recordings.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A
Time frame: From first dose to 14 days post last dose (Up to approximately 13 weeks)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities. Severe= An event preventing normal everyday activities. (An AE that is assessed as severe should not be confused with a SAE. Severe is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.)

21 secondary outcomes

Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A - MYH7 - MYK-491	12	11
Part A - TTN - MYK-491	14	14
Part A - DCM-Genetic - MYK-491	5	5
Part A - DCM-Non Genetic - MYK-491	10	10
Part B - MYH7 - MYK-491	0	0
Part B - TTN - MYK-491	0	0
Part B - DCM-Non Genetic - MYK-491	0	0

Primary outcome: Number of Participants With Adverse Events (AEs) in Part A

Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks). Count of participants. Unit: Participants

Measure	Part A - MYH7 - MYK-491 n = 12	Part A - TTN - MYK-491 n = 14	Part A - DCM-Genetic - MYK-491 n = 5	Part A - DCM-Non Genetic - MYK-491 n = 10
Value	9	9	4	4

Population analysed: All treated participants in Part A as pre-specified in protocol.

Primary outcome: Number of Participants With Serious Adverse Events (SAEs) in Part A

Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks). Count of participants. Unit: Participants

Measure	Part A - MYH7 - MYK-491 n = 12	Part A - TTN - MYK-491 n = 14	Part A - DCM-Genetic - MYK-491 n = 5	Part A - DCM-Non Genetic - MYK-491 n = 10
Value	0	0	0	0

Population analysed: All treated participants in Part A as pre-specified in protocol.

Primary outcome: Number of Participants With Safety Laboratory Assessments by Intensity in Part A

Time frame: From first dose to 14 days post last dose (Up to approximately 13 weeks). Count of participants. Unit: Participants

Measure	Part A - MYH7 - MYK-491 n = 12	Part A - TTN - MYK-491 n = 14	Part A - DCM-Genetic - MYK-491 n = 5
Alanine aminotransferase increased Mild	1	0	1
Aspartate aminotransferase increased Mild	1	0	1
Blood creatinine increased Moderate	0	0	1
Fibrin D dimer increased Moderate	0	1	0
Hyperkalaemia Mild	0	1	0
Hyperkalaemia Moderate	0	0	1

Population analysed: All treated participants in Part A as pre-specified in protocol

Primary outcome: Number of Participants With Clinically Significant Changes in Physical Examinations in Part A

Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks). Count of participants. Unit: Participants

Measure	Part A - MYH7 - MYK-491 n = 12	Part A - TTN - MYK-491 n = 14	Part A - DCM-Genetic - MYK-491 n = 5	Part A - DCM-Non Genetic - MYK-491 n = 10
Value	0	1	0	0

Population analysed: All treated participants in Part A as pre-specified in protocol

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events, and other adverse events are from first dose until the end of the study visit for the participant (Up to approximately 115 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - MYH7 - MYK-491 25 mg BID	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Part A - TTN - MYK-491 25 mg BID	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
Part A - DCM-Genetic - MYK-491 25 mg BID	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Part A - DCM-Non Genetic - MYK-491 25 mg BID	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Part A - MYH7 - MYK-491 50 mg BID	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Part A - TTN - MYK-491 50 mg BID	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14
Part A - DCM-Genetic - MYK-491 50 mg BID	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Part A - DCM-Non Genetic - MYK-491 50 mg BID	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Part A - DCM-Genetic - MYK-491 10 mg BID	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Part A - DCM-Non Genetic - MYK-491 10 mg BID	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Part B - MYH7 - MYK-491 25 mg BID	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part B - MYH7 - MYK-491 50 mg BID	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Part B - TTN - MYK-491 50 mg BID	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Part B - DCM-Non Genetic - MYK-491 50 mg BID	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Part B - MYH7 - MYK-491 75 mg BID	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Part B - TTN - MYK-491 75 mg BID	2 of 4 (50%)	4 of 4 (100%)	0 of 4
Part B - DCM-Non Genetic - MYK-491 75 mg BID	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41217321Lakdawala NK, Hershberger RE, Garcia-Pavia P, Elliott PM, Ginns J, Meder B, Solomon S, Cunningham JW, Gimeno JR, Barriales-Villa R, Adler E, Gerull B, Pereira NL, Halliday BP, Li W, Jarugula P, Maruyama S, Mohran SE, Papadaki M, Anto AR, Anderson RL, Rodriguez HM, Del Rio CL, Edelberg JM, Kurio G, Maya J, Januzzi JL. Danicamtiv, a Selective Agonist of Cardiac Myosin, for Dilated Cardiomyopathy: A Phase 2 Open-Label Trial. J Am Coll Cardiol. 2025 Dec 23;86(25):2598-2612. doi: 10.1016/j.jacc.2025.09.1511. Epub 2025 Sep 29.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

19 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing danicamtiv in people with Primary Familial Dilated Cardiomyopathy, run by Bristol-Myers Squibb at 19 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Spain, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) in Part A (time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.