Trial · NCT05414175
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
NCT05414175, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2024-12-04
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy. Trials, record NCT05414175. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05414175
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
- NCT number
- NCT05414175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 38 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Cardiomyopathy, Hypertrophic Obstructive
- Interventions
- Mavacamten
- First posted
- 2022-06-10
- Last updated
- 2026-01-27
- Results first posted
- 2024-12-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Post-exercise Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30 | At Baseline and Week 30 | The post-exercise LVOT gradient was measured from echocardiograms obtained at baseline and week 30 following a study-specified exercise protocol and read by the doppler echocardiography. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment. |
| Secondary | Change From Baseline in Kansas City Cardiomyopathy Questionnaire 23-item Version (KCCQ-23) Clinical Summary Score (CSS) at Week 30 | At Baseline and Week 30 | The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 to 100 with higher scores representing less severe symptoms and/or physical limitations. The CSS is a mean of the TSS and the PL score. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment. |
| Secondary | Percentage of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 30 | Baseline and at Week 30 | The NYHA Functional Classification of Heart Failure (HF) assigns participants to 1 of 4 categories based on the participant's symptoms. Class I (No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea); Class II (Slight limitation of physical activity, Comfortable at rest, Ordinary physical activity results in fatigue, palpitation, dyspnea); Class III (Marked limitation of physical activity, Comfortable at rest, Less-than ordinary-activity causes fatigue, palpitation, or dyspnea) and Class IV (Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases). Improvement is defined as participant moving to lower class category from a higher one. Baseline is defined as last non-missing measurement prior to the first dose. |
| Secondary | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 30 | At baseline and week 30 | Blood samples were collected for assessing the concentration of NT-proBNP. Baseline is defined as last non-missing measurement prior to the first dose. |
| Secondary | Change From Baseline in Cardiac Troponin I at Week 30 | At baseline and week 30 | Blood samples were collected for assessing cardiac troponins. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment. |
| Secondary | Change From Baseline in Cardiac Troponin T at Week 30 | At baseline and week 30 | Blood samples were collected for assessing cardiac troponins. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Post-exercise Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30 | At Baseline and Week 30 | Intent-to-treat population. Only those participants with data available at the specified time points were analyzed. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Kansas City Cardiomyopathy Questionnaire 23-item Version (KCCQ-23) Clinical Summary Score (CSS) at Week 30 | At Baseline and Week 30 | Intent to Treat Population. Only those participants with data available at the specified time points were analyzed. | Score on a Scale | MEAN |
| SECONDARY | Percentage of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 30 | Baseline and at Week 30 | Intent To Treat Population. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 30 | At baseline and week 30 | Intent to Treat Population. Only those participants with data available at the specified time points were analyzed. | nanogram per liter (ng/L) | MEDIAN |
| SECONDARY | Change From Baseline in Cardiac Troponin I at Week 30 | At baseline and week 30 | Intent to Treat population. Only those participants with data available at the specified time points were analyzed. | ng/L | MEDIAN |
| SECONDARY | Change From Baseline in Cardiac Troponin T at Week 30 | At baseline and week 30 | Intent to Treat Population. Only those participants with data available at the specified time points were analyzed. | ng/L | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Post-exercise Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30 | Mavacamten | -60.6963 | Standard Deviation 31.55674 | millimeters of mercury (mmHg) | |
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire 23-item Version (KCCQ-23) Clinical Summary Score (CSS) at Week 30 | Mavacamten | 9.766 | Standard Deviation 16.8588 | Score on a Scale | |
| Percentage of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 30 | Mavacamten | 63.2 | Percentage of participants | ||
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 30 | Mavacamten | -738.0 | Full Range -3101 to 590 | nanogram per liter (ng/L) | |
| Change From Baseline in Cardiac Troponin I at Week 30 | Mavacamten | -10.920 | Full Range -226.42 to 0.80 | ng/L | |
| Change From Baseline in Cardiac Troponin T at Week 30 | Mavacamten | -4.95 | Full Range -19.2 to 0.3 | ng/L |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mavacamten | 38 | |
| Overall Study | Intent to Treat Population | Mavacamten | 38 | |
| Overall Study | Safety Population | Mavacamten | 38 | |
| Overall Study | COMPLETED | Mavacamten | 36 | |
| Overall Study | NOT COMPLETED | Mavacamten | 2 |
Source ClinicalTrials.gov
Adverse events21
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 fibrillation | Cardiac disorders | Mavacamten | 3 | 38 | |
| other | Palpitations | Cardiac disorders | Mavacamten | 2 | 38 | |
| other | Cataract | Eye disorders | Mavacamten | 2 | 38 | |
| other | Abdominal pain | Gastrointestinal disorders | Mavacamten | 2 | 38 | |
| other | Malaise | General disorders | Mavacamten | 2 | 38 | |
| other | Pyrexia | General disorders | Mavacamten | 3 | 38 | |
| other | Bronchitis | Infections and infestations | Mavacamten | 2 | 38 | |
| other | COVID-19 | Infections and infestations | Mavacamten | 8 | 38 | |
| other | Nasopharyngitis | Infections and infestations | Mavacamten | 6 | 38 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Mavacamten | 2 | 38 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mavacamten | 0 | 38 |
| Total, other adverse events | Mavacamten | 20 | 38 |
| Total, serious adverse events | Mavacamten | 6 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05414175
GET https://conductscience.org/api/trials/v1/NCT05414175/events?page=2