Trial · NCT05186818
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
NCT05186818, Phase 3, Completed, Cytokinetics; results first posted 2026-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM. Trials, record NCT05186818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05186818
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
- NCT number
- NCT05186818
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 282 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- Interventions
- Aficamten (5 mg, 10 mg, 15 mg, and 20 mg), Placebo to match aficamten
- First posted
- 2022-01-11
- Last updated
- 2026-03-03
- Other registries' IDs
- eudract:2021-003536-92
- Results first posted
- 2026-03-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in pVO2 at Week 24 | Baseline to Week 24 | The effect of CK-3773274 on exercise capacity in participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) was determined through changes in peak oxygen uptake (pVO2) after 24 weeks of treatment. pVO2 was measured by cardiopulmonary exercise testing (CPET) on a treadmill or bicycle. A higher pVO2 indicates better cardiorespiratory fitness. |
| Secondary | Change From Baseline in KCCQ-CSS at Week 24 | Baseline to Week 24 | The effect of aficamten on patient health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a patient-reported outcome designed to assess the physical limitations, symptoms, self-efficacy, social limitation, and quality of life of patients with heart failure symptoms. The KCCQ-Clinical Symptoms Score (KCCQ-CSS) is scored on a scale from 0 to 100, with higher scores indicating better physical functioning and symptoms. |
| Secondary | Change From Baseline in KCCQ-CSS at Week 12 | Baseline to Week 12 | The effect of aficamten on patient health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a patient-reported outcome designed to assess the physical limitations, symptoms, self-efficacy, social limitation, and quality of life of patients with heart failure symptoms. The KCCQ-Clinical Symptoms Score (KCCQ-CSS) is scored on a scale from 0 to 100, with higher scores indicating better physical functioning and symptoms. |
| Secondary | Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24 | Baseline to Week 24 | The effect of aficamten on NYHA functional classification was evaluated through changes observed from baseline through 24 weeks of treatment. |
| Secondary | Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12 | Baseline to Week 12 | The effect of aficamten on NYHA functional classification was evaluated through changes observed from baseline through 12 weeks of treatment. |
| Secondary | Change From Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G) at Week 24 | Baseline to Week 24 | The effect of aficamten treatment on Valsalva LVOT-G was evaluated through changes from baseline to Week 24. |
| Secondary | Change From Baseline in Valsalva LVOT-G at Week 12 | Baseline to Week 12 | The effect of aficamten treatment on Valsalva LVOT-G was evaluated through changes from baseline to Week 12. |
| Secondary | Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 24 | Baseline to Week 24 | The effect of aficamten treatment on Valsalva LVOT-G was evaluated through changes from baseline to Week 24. |
| Secondary | Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 12 | Baseline to Week 12 | The effect of aficamten treatment on Valsalva LVOT-G was evaluated through changes from baseline to Week 12. |
| Secondary | Duration of SRT Eligibility During the 24-week Treatment Period for Participants Who Were SRT Eligible at Baseline | Baseline to Week 24 | The effect of aficamten treatment on the duration of septal reduction therapy (SRT) eligibility was evaluated over the 24- week treatment period. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 pVO2 at Week 24 | Baseline to Week 24 | Full Analysis Set (consisting of all randomized participants) | mL/kg/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in KCCQ-CSS at Week 24 | Baseline to Week 24 | Full Analysis Set (consisting of all randomized participants) | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in KCCQ-CSS at Week 12 | Baseline to Week 12 | Full Analysis Set (consisting of all randomized participants) | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24 | Baseline to Week 24 | Full Analysis Set (consisting of all randomized participants) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12 | Baseline to Week 12 | Full Analysis Set (consisting of all randomized participants) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G) at Week 24 | Baseline to Week 24 | Full Analysis Set (consisting of all randomized participants) | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Valsalva LVOT-G at Week 12 | Baseline to Week 12 | Full Analysis Set (consisting of all randomized participants) | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 24 | Baseline to Week 24 | Full Analysis Set (consisting of all randomized participants) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 12 | Baseline to Week 12 | Full Analysis Set (consisting of all randomized participants) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of SRT Eligibility During the 24-week Treatment Period for Participants Who Were SRT Eligible at Baseline | Baseline to Week 24 | Participants in the Full Analysis Set who were SRT eligible at baseline | days | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
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 pVO2 at Week 24 | Aficamten up to 20 mg | 1.76 | Standard Error 0.25 | mL/kg/min | |
| Change From Baseline in pVO2 at Week 24 | Placebo to Match Aficamten | 0.02 | Standard Error 0.25 | mL/kg/min | |
| Change From Baseline in KCCQ-CSS at Week 24 | Aficamten up to 20 mg | 11.6 | Standard Error 1.0 | score on a scale | |
| Change From Baseline in KCCQ-CSS at Week 24 | Placebo to Match Aficamten | 4.3 | Standard Error 1.0 | score on a scale | |
| Change From Baseline in KCCQ-CSS at Week 12 | Aficamten up to 20 mg | 11.1 | Standard Error 0.9 | score on a scale | |
| Change From Baseline in KCCQ-CSS at Week 12 | Placebo to Match Aficamten | 4.0 | Standard Error 0.9 | score on a scale | |
| Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24 | Aficamten up to 20 mg | 83 | Participants | ||
| Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24 | Placebo to Match Aficamten | 34 | Participants | ||
| Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12 | Aficamten up to 20 mg | 69 | Participants | ||
| Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12 | Placebo to Match Aficamten | 25 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aficamten up to 20 mg | 142 | |
| Overall Study | STARTED | Placebo to Match Aficamten | 140 | |
| Overall Study | COMPLETED | Aficamten up to 20 mg | 137 | |
| Overall Study | COMPLETED | Placebo to Match Aficamten | 136 | |
| Overall Study | NOT COMPLETED | Aficamten up to 20 mg | 5 | |
| Overall Study | NOT COMPLETED | Placebo to Match Aficamten | 4 |
Source ClinicalTrials.gov
Adverse events66
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 | Angina pectoris | Cardiac disorders | Aficamten up to 20 mg | 3 | 142 | 4 |
| other | Angina pectoris | Cardiac disorders | Placebo to Match Aficamten | 7 | 140 | 12 |
| other | Palpitations | Cardiac disorders | Aficamten up to 20 mg | 10 | 142 | 12 |
| other | Palpitations | Cardiac disorders | Placebo to Match Aficamten | 4 | 140 | 5 |
| other | Fatigue | General disorders | Aficamten up to 20 mg | 3 | 142 | 3 |
| other | Fatigue | General disorders | Placebo to Match Aficamten | 7 | 140 | 9 |
| other | COVID-19 | Infections and infestations | Aficamten up to 20 mg | 8 | 142 | 8 |
| other | COVID-19 | Infections and infestations | Placebo to Match Aficamten | 9 | 140 | 11 |
| other | Upper respiratory tract infection | Infections and infestations | Aficamten up to 20 mg | 9 | 142 | 13 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo to Match Aficamten | 12 | 140 | 16 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aficamten up to 20 mg | 0 | 142 |
| Total, all-cause mortality | Placebo to Match Aficamten | 0 | 140 |
| Total, other adverse events | Aficamten up to 20 mg | 44 | 142 |
| Total, other adverse events | Placebo to Match Aficamten | 46 | 140 |
| Total, serious adverse events | Aficamten up to 20 mg | 8 | 142 |
| Total, serious adverse events | Placebo to Match Aficamten | 13 | 140 |
Source ClinicalTrials.gov
Papers13
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aficamten up to 20 mg vs Placebo to Match Aficamten: Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12 | Trial comparisons |
| Aficamten up to 20 mg vs Placebo to Match Aficamten: Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 24 | Trial comparisons |
| Aficamten up to 20 mg vs Placebo to Match Aficamten: Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 12 | Trial comparisons |
| Aficamten up to 20 mg vs Placebo to Match Aficamten: Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24 | Trial comparisons |
| Aficamten up to 20 mg vs Placebo to Match Aficamten: deaths from any cause | Trial comparisons |
| Aficamten up to 20 mg vs Placebo to Match Aficamten: 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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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GET https://conductscience.org/api/trials/v1/NCT05186818/results?page=2