Trial · NCT05582395
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
NCT05582395, Phase 3, Terminated, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy. Trials, record NCT05582395. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05582395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
- NCT number
- NCT05582395
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 580 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Cardiomyopathy, Hypertrophic
- Interventions
- Mavacamten, Placebo
- First posted
- 2022-10-17
- Last updated
- 2026-09-18
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 KCCQ-23 CSS at Week 48 | From First dose to week 48 | 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. |
| Primary | Change From Baseline in pVO2 at Week 48 | From First dose to week 48 | Clinically meaningful mean change from baseline(1.4ml/kg/min) of pVO2 at Week 48. |
| Secondary | Change From Baseline in VE/VCO2 Slope at Week 48 | From First dose to week 48 | VE/VCO₂ slope was assessed using cardiopulmonary exercise testing (CPET). The slope was calculated as the linear regression of minute ventilation (VE) against carbon dioxide production (VCO₂). A decrease in VE/VCO₂ slope reflects improved ventilatory efficiency. |
| Secondary | Mean Change From Baseline in NT-proBNP to Week 48 | From First dose to week 48 | 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 | Percentage of Participants With at Least 1 Class of NYHA Improvement From Baseline at Week 48 | From First dose to week 48 | Participants with \\\>= 1 NYHA function class improvement. The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
| Secondary | Mean Change From Baseline in HCMSQ SoB Domain Score at Week 48 | From First dose to week 48 | The HCMSQ is a self- administered, 9-item questionnaire that assesses the core symptoms of HCM (shortness of breath, tiredness/fatigue, heart palpitations, chest pain, dizziness, and syncope). At each visit, a 7-day period will be defined, ending on the last day with a non-missing HCMSQ score prior to the actual clinic visit (or first dose date if baseline). If the participant completes the HCMSQ for 4 or more days within this period, the weekly average HCMSQ score will be calculated. If fewer than 4 days are completed, other 7-day periods will be considered. For baseline, any 7-day period with at least 4 days of HCMSQ prior to the first dose or randomization date (if first dose date is missing) will be used. Each domain of the SoB scale is scored 1 to 6. The scores are added together to give a total score. Lower scores indicating low to no shortness of breath, higher scores indicating frequent episodes of shortness of breath. the lower the score the better. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT05582395
GET https://conductscience.org/api/trials/v1/NCT05582395/registered