Trial · NCT02842242
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
NCT02842242, Phase 2, Completed, MyoKardia, Inc.; results first posted 2020-02-05
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction. Trials, record NCT02842242. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02842242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
- NCT number
- NCT02842242
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- MyoKardia, Inc.
- Conditions
- Cardiomyopathy, Hypertrophic Obstructive, Left Ventricular Outflow Tract Obstruction
- Interventions
- MYK-461
- First posted
- 2016-07-22
- Last updated
- 2021-06-08
- Results first posted
- 2020-02-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12 | Baseline and Week 12 | Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography. |
| Secondary | Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg | Baseline and Week 12 | LVOT gradients are assessed after a treadmill stress test by echocardiography. |
| Secondary | Change in Dyspnea Symptom Score From Baseline to Week 12 | Baseline and Week 12 | The scale name is Dyspnea Numeric Rating Scale (NRS). It is intended to measure how much shortness of breath you have had in the past week. 0 = no shortness of breath and 10 = shortness of breath as the worst possible. |
| Secondary | Change in Peak VO2 From Baseline to Week 12 | Baseline and Week 12 | Peak VO2 is assessed using a cardiopulmonary exercise test. |
| Secondary | Change in VE/VCO2 From Baseline to Week 12 | Baseline and Week 12 | VE/VCO2 is assessed from cardiopulmonary exercise testing results. |
| Secondary | Change in Resting LVEF From Baseline to Week 12 | Baseline and Week 12 | LVEF is assessed by echocardiography. |
| Secondary | Change in LV Fractional Shortening (LVFS) From Baseline to Week 12 | Baseline and Week 12 | LVFS is assessed using echocardiography measures. |
| Secondary | Change in Global Longitudinal Strain (GLS) From Baseline to Week 12 | Baseline and Week 12 | GLS is assessed using echocardiography measures. |
| Secondary | Change in Post-exercise Peak LVOT Gradient From Week 12 to Week 16 | Weeks 12 and 16 | Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography. |
| Other | Change in NYHA Functional Class From Baseline to Week 12 | Baseline and Week 12 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12 | Baseline and Week 12 | mm Hg | MEAN | |
| SECONDARY | Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg | Baseline and Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Dyspnea Symptom Score From Baseline to Week 12 | Baseline and Week 12 | units on a scale | MEAN | |
| SECONDARY | Change in Peak VO2 From Baseline to Week 12 | Baseline and Week 12 | mL/kg/min | MEAN | |
| SECONDARY | Change in VE/VCO2 From Baseline to Week 12 | Baseline and Week 12 | Ratio | MEAN | |
| SECONDARY | Change in Resting LVEF From Baseline to Week 12 | Baseline and Week 12 | Percent change | MEAN | |
| SECONDARY | Change in LV Fractional Shortening (LVFS) From Baseline to Week 12 | Baseline and Week 12 | Percent | MEAN | |
| SECONDARY | Change in Global Longitudinal Strain (GLS) From Baseline to Week 12 | Baseline and Week 12 | Percent | MEAN | |
| SECONDARY | Change in Post-exercise Peak LVOT Gradient From Week 12 to Week 16 | Weeks 12 and 16 | mm Hg | MEAN | |
| OTHER_PRE_SPECIFIED | Change in NYHA Functional Class From Baseline to Week 12 | Baseline and Week 12 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12 | Cohort A | -89.5 | 95% Confidence Interval -138.3 to -40.7 | mm Hg | |
| Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12 | Cohort B | -25.0 | 95% Confidence Interval -47.1 to -3.0 | mm Hg | |
| Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg | Cohort A | 8 | Participants | ||
| Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg | Cohort B | 0 | Participants | ||
| Change in Dyspnea Symptom Score From Baseline to Week 12 | Cohort A | -3.1 | 95% Confidence Interval -4.1 to -2.1 | units on a scale | |
| Change in Dyspnea Symptom Score From Baseline to Week 12 | Cohort B | -3.0 | 95% Confidence Interval -5.0 to -1.0 | units on a scale | |
| Change in Peak VO2 From Baseline to Week 12 | Cohort A | 3.5 | 95% Confidence Interval 1.2 to 5.9 | mL/kg/min | |
| Change in Peak VO2 From Baseline to Week 12 | Cohort B | 1.7 | 95% Confidence Interval 0.03 to 3.3 | mL/kg/min | |
| Change in VE/VCO2 From Baseline to Week 12 | Cohort A | -2.2 | 95% Confidence Interval -6.1 to 1.7 | Ratio | |
| Change in VE/VCO2 From Baseline to Week 12 | Cohort B | -2.5 | 95% Confidence Interval -4.3 to -0.7 | Ratio |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 11 | |
| Overall Study | STARTED | Cohort B | 10 | |
| Overall Study | COMPLETED | Cohort A | 10 | |
| Overall Study | COMPLETED | Cohort B | 10 | |
| Overall Study | NOT COMPLETED | Cohort A | 1 | |
| Overall Study | NOT COMPLETED | Cohort B | 0 |
Source ClinicalTrials.gov
Adverse events148
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 | Ventricular Tachycardia | Cardiac disorders | Cohort A | 1 | 11 | |
| other | Ventricular Tachycardia | Cardiac disorders | Cohort B | 4 | 10 | |
| other | Atrial Fibrillation | Cardiac disorders | Cohort A | 3 | 11 | |
| other | Atrial Fibrillation | Cardiac disorders | Cohort B | 1 | 10 | |
| other | Headache | Nervous system disorders | Cohort A | 3 | 11 | |
| other | Headache | Nervous system disorders | Cohort B | 2 | 10 | |
| other | Dizziness | Nervous system disorders | Cohort A | 1 | 11 | |
| other | Dizziness | Nervous system disorders | Cohort B | 3 | 10 | |
| other | Nausea | Gastrointestinal disorders | Cohort A | 2 | 11 | |
| other | Nausea | Gastrointestinal disorders | Cohort B | 0 | 10 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 0 | 11 |
| Total, all-cause mortality | Cohort B | 0 | 10 |
| Total, other adverse events | Cohort A | 10 | 11 |
| Total, other adverse events | Cohort B | 10 | 10 |
| Total, serious adverse events | Cohort A | 1 | 11 |
| Total, serious adverse events | Cohort B | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31035291 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A vs Cohort B: Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg | Trial comparisons |
| Cohort A vs Cohort B: deaths from any cause | Trial comparisons |
| Cohort A vs Cohort B: serious adverse events | Trial comparisons |
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/NCT02842242
GET https://conductscience.org/api/trials/v1/NCT02842242/events?page=2