Trial · NCT04766892
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
NCT04766892, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2025-03-20
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT. Trials, record NCT04766892. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04766892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
- NCT number
- NCT04766892
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- mavacamten
- First posted
- 2021-02-23
- Last updated
- 2025-03-20
- Results first posted
- 2025-03-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. |
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. AEs of special interest include: Symptomatic overdose, teratogenicity, and LVEF ≤30% |
| Primary | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Treatment-emergent serious adverse event (TESAE) is defined as any untoward medical occurrence at any dose that: Results in death, Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, Results in a congenital abnormality or birth defect, Is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above. |
| Primary | Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Blood samples were collected to assess the abnormalities in laboratory parameters. |
| Primary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. |
| Primary | Number of Participants With Cardiac Rhythm Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. |
| Primary | Ratio to Baseline at Week 26 in Resting N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Levels | At Week 26 | Ratio to baseline in N-terminal pro B-type natriuretic peptide levels. The baseline value is defined as the last available value before the first administration of study drug. |
| Primary | Ratio to Baseline at Week 26 in Resting High Sensitivity Cardiac Troponin T (Hs-cTnT) Levels Assessed by High-Sensitivity Assay | At Week 26 | Ratio to Baseline in resting high sensitivity cardiac troponin T (hs-cTnT) levels. The baseline value is defined as the last available value before the first administration of study drug. |
Source ClinicalTrials.gov
Outcomes8
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 Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Safety Analysis Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Special Interest (AESIs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Safety Analysis Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Safety Analysis Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Safety Analysis Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Safety Analysis Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Cardiac Rhythm Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the first dose of study drug through 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days) | Safety Analysis Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Ratio to Baseline at Week 26 in Resting N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Levels | At Week 26 | All Intention-To-Treat Participants | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Ratio to Baseline at Week 26 in Resting High Sensitivity Cardiac Troponin T (Hs-cTnT) Levels Assessed by High-Sensitivity Assay | At Week 26 | All Intention-To-Treat Participants | Ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group10
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 Treatment-Emergent Adverse Events (TEAEs) | Mavacamten | 23 | Participants | ||
| Number of Participants With Adverse Events of Special Interest (AESIs) | Mavacamten | Symptomatic Overdose | 0 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Mavacamten | Outcomes of Pregnancy | 0 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Mavacamten | Left Ventricular Ejection Fraction (LVEF) ≤30% | 0 | Participants | |
| Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | Mavacamten | 5 | Participants | ||
| Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavacamten | 4 | Participants | ||
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavacamten | 4 | Participants | ||
| Number of Participants With Cardiac Rhythm Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavacamten | 5 | Participants | ||
| Ratio to Baseline at Week 26 in Resting N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Levels | Mavacamten | 0.7354 | 95% Confidence Interval 0.5612 to 0.9637 | Ratio | |
| Ratio to Baseline at Week 26 in Resting High Sensitivity Cardiac Troponin T (Hs-cTnT) Levels Assessed by High-Sensitivity Assay | Mavacamten | 0.8645 | 95% Confidence Interval 0.7711 to 0.9693 | Ratio |
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 | 30 | |
| Overall Study | Safety Population | Mavacamten | 30 | |
| Overall Study | Intent to Treat Population | Mavacamten | 30 | |
| Overall Study | COMPLETED | Mavacamten | 24 | |
| Overall Study | NOT COMPLETED | Mavacamten | 6 |
Source ClinicalTrials.gov
Adverse events17
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 | Mavacamten | 2 | 30 | |
| other | Asthenia | General disorders | Mavacamten | 2 | 30 | |
| other | COVID-19 | Infections and infestations | Mavacamten | 4 | 30 | |
| other | Upper respiratory tract infection | Infections and infestations | Mavacamten | 3 | 30 | |
| other | Urinary tract infection | Infections and infestations | Mavacamten | 2 | 30 | |
| other | Fall | Injury, poisoning and procedural complications | Mavacamten | 4 | 30 | |
| other | Dizziness | Nervous system disorders | Mavacamten | 4 | 30 | |
| other | Headache | Nervous system disorders | Mavacamten | 3 | 30 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Mavacamten | 3 | 30 | |
| other | Hypertension | Vascular disorders | Mavacamten | 3 | 30 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mavacamten | 1 | 30 |
| Total, other adverse events | Mavacamten | 18 | 30 |
| Total, serious adverse events | Mavacamten | 5 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39347697 | 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/NCT04766892
GET https://conductscience.org/api/trials/v1/NCT04766892/registered