Trial · NCT04572893
Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
NCT04572893, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2025-05-21
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities. Trials, record NCT04572893. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04572893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
- NCT number
- NCT04572893
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Primary Familial Dilated Cardiomyopathy
- Interventions
- danicamtiv
- First posted
- 2020-10-01
- Last updated
- 2025-05-21
- Other registries' IDs
- eudract:2019-003626-24
- Results first posted
- 2025-05-21
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) in Part A | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) in Part A | 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. |
| Primary | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | 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. |
| Primary | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | Number of participants with clinically significant changes in physical examinations. |
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | Number of participants with clinically significant changes in vital signs. |
| Primary | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | 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. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | 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.) |
| Secondary | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | 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 | 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. |
| Secondary | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | 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 | 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. |
| Secondary | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | 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 | 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. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | From first dose to 14 days post last dose (Up to approximately 13 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | 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 | All treated participants with baseline and post baseline measurements at the specified timepoints | msec | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | From first dose to 14 days post last dose (Up to approximately 13 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | 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 | All treated participants with baseline and post baseline measurements at the specified timepoints | mL | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | 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 | All treated participants with baseline and post baseline measurements at the specified timepoints | percentage | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group610
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) in Part A | Part A - MYH7 - MYK-491 | 9 | Participants | ||
| Number of Participants With Adverse Events (AEs) in Part A | Part A - TTN - MYK-491 | 9 | Participants | ||
| Number of Participants With Adverse Events (AEs) in Part A | Part A - DCM-Genetic - MYK-491 | 4 | Participants | ||
| Number of Participants With Adverse Events (AEs) in Part A | Part A - DCM-Non Genetic - MYK-491 | 4 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) in Part A | Part A - MYH7 - MYK-491 | 0 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) in Part A | Part A - TTN - MYK-491 | 0 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) in Part A | Part A - DCM-Genetic - MYK-491 | 0 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) in Part A | Part A - DCM-Non Genetic - MYK-491 | 0 | Participants | ||
| Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Part A - MYH7 - MYK-491 | Alanine aminotransferase increased Mild | 1 | Participants | |
| Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Part A - TTN - MYK-491 | Alanine aminotransferase increased Mild | 0 | Participants |
1 to 10 of 610Source ClinicalTrials.gov
See all 610 results by groupParticipant flow49
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A - MYH7 - MYK-491 | 12 | |
| Part A | STARTED | Part A - TTN - MYK-491 | 14 | |
| Part A | STARTED | Part A - DCM-Genetic - MYK-491 | 5 | |
| Part A | STARTED | Part A - DCM-Non Genetic - MYK-491 | 10 | |
| Part A | STARTED | Part B - MYH7 - MYK-491 | 0 | |
| Part A | STARTED | Part B - TTN - MYK-491 | 0 | |
| Part A | STARTED | Part B - DCM-Non Genetic - MYK-491 | 0 | |
| Part A | Started Part B | Part A - MYH7 - MYK-491 | 8 | |
| Part A | Started Part B | Part A - TTN - MYK-491 | 7 | |
| Part A | Started Part B | Part A - DCM-Genetic - MYK-491 | 0 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 participant flowAdverse events1,394
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial flutter | Cardiac disorders | Part A - MYH7 - MYK-491 25 mg BID | 0 | 12 | |
| other | Atrial flutter | Cardiac disorders | Part A - TTN - MYK-491 25 mg BID | 0 | 14 | |
| other | Atrial flutter | Cardiac disorders | Part A - DCM-Genetic - MYK-491 25 mg BID | 0 | 5 | |
| other | Atrial flutter | Cardiac disorders | Part A - DCM-Non Genetic - MYK-491 25 mg BID | 0 | 10 | |
| other | Atrial flutter | Cardiac disorders | Part A - MYH7 - MYK-491 50 mg BID | 0 | 12 | |
| other | Atrial flutter | Cardiac disorders | Part A - TTN - MYK-491 50 mg BID | 0 | 14 | |
| other | Atrial flutter | Cardiac disorders | Part A - DCM-Genetic - MYK-491 50 mg BID | 0 | 4 | |
| other | Atrial flutter | Cardiac disorders | Part A - DCM-Non Genetic - MYK-491 50 mg BID | 0 | 9 | |
| other | Atrial flutter | Cardiac disorders | Part A - DCM-Genetic - MYK-491 10 mg BID | 0 | 1 | |
| other | Atrial flutter | Cardiac disorders | Part A - DCM-Non Genetic - MYK-491 10 mg BID | 0 | 1 |
1 to 10 of 1,394Source ClinicalTrials.gov
See all 1,394 adverse eventsAdverse event totals51
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A - MYH7 - MYK-491 25 mg BID | 0 | 12 |
| Total, all-cause mortality | Part A - TTN - MYK-491 25 mg BID | 0 | 14 |
| Total, all-cause mortality | Part A - DCM-Genetic - MYK-491 25 mg BID | 0 | 5 |
| Total, all-cause mortality | Part A - DCM-Non Genetic - MYK-491 25 mg BID | 0 | 10 |
| Total, all-cause mortality | Part A - MYH7 - MYK-491 50 mg BID | 0 | 12 |
| Total, all-cause mortality | Part A - TTN - MYK-491 50 mg BID | 0 | 14 |
| Total, all-cause mortality | Part A - DCM-Genetic - MYK-491 50 mg BID | 0 | 4 |
| Total, all-cause mortality | Part A - DCM-Non Genetic - MYK-491 50 mg BID | 0 | 9 |
| Total, all-cause mortality | Part A - DCM-Genetic - MYK-491 10 mg BID | 0 | 1 |
| Total, all-cause mortality | Part A - DCM-Non Genetic - MYK-491 10 mg BID | 0 | 1 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41217321 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04572893
GET https://conductscience.org/api/trials/v1/NCT04572893/registered?page=2