Trial · NCT04219826
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
NCT04219826, Phase 2, Completed, Cytokinetics; results first posted 2026-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy. Trials, record NCT04219826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04219826
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
- NCT number
- NCT04219826
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Interventions
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg), Placebo for CK-3773274
- First posted
- 2020-01-07
- Last updated
- 2026-02-24
- Other registries' IDs
- eudract:2019-002785-12
- Results first posted
- 2026-02-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | 14 weeks | Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM. |
| Primary | Incidence of Left Ventricular Ejection Fraction (LVEF) < 50% | 14 weeks | Participant incidence of LVEF \< 50% as assessed by the core laboratory assessment. |
| Primary | Incidence of Serious Adverse Events (SAEs) | 14 weeks | Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM. |
| Secondary | Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting Left Ventricular Outflow Track Gradient (LVOT-G) | Baseline and 10 weeks | Concentration-response relationship of CK-3773274 on the resting LVOT-G on echocardiogram over 10 weeks of treatment in participants with (oHCM) obstructive hypertrophic cardiomyopathy (oHCM) (Cohorts 1, 2, 3 only) |
| Secondary | Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G | Baseline and 10 Weeks | Concentration-response relationship of CK-3773274 on the post-Valsalva LVOT-G on echocardiogram over 10 weeks of treatment in participants with oHCM (Cohorts 1, 2, 3 only) |
| Secondary | Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. | Baseline and 10 Weeks | Dose response relationship on resting LVOT-G of CK-3773274 in participants with oHCM (Cohorts 1, 2, 3 only) |
| Secondary | Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. | 10 weeks | Dose response relationship of CK-3773274 on post-Valsalva LVOT-G in participants with symptomatic oHCM (Cohorts 1, 2, 3 only) |
| Secondary | Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF | Day 1 to End of Study (EOS) (Week 14) | Concentration-response relationship of CK-3773274 on LVEF over 10 weeks of treatment in participants with HCM |
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 | Incidence of Adverse Events (AEs) | 14 weeks | Safety Analysis Set included all participants who received at least 1 dose of investigational product (IP), aficamten or placebo | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Left Ventricular Ejection Fraction (LVEF) < 50% | 14 weeks | Safety Analysis Set included all participants who received at least 1 dose of IP, aficamten or placebo | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Serious Adverse Events (SAEs) | 14 weeks | Safety Analysis Set included all participants who received at least 1 dose of IP, aficamten or placebo | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting Left Ventricular Outflow Track Gradient (LVOT-G) | Baseline and 10 weeks | The Pharmacodynamics Analysis Set (PDS) included all participants who received at least 1 dose of IP and had a baseline and at least 1 post-baseline core laboratory echocardiography assessment including non-missing LVEF measurements and non-missing LVOT-G at rest. | mmHg per ng/ML | LEAST_SQUARES_MEAN |
| SECONDARY | Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G | Baseline and 10 Weeks | The Pharmacodynamics Analysis Set (PDS) included all participants who received at least 1 dose of IP and had a baseline and at least 1 post-baseline core laboratory echocardiography assessment including non-missing LVEF measurements and non-missing LVOT-G at rest. | mmHg per ng/ML | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. | Baseline and 10 Weeks | The Pharmacodynamics Analysis Set (PDS) included all participants who received at least 1 dose of IP and had a baseline and at least 1 post-baseline core laboratory echocardiography assessment including non-missing LVEF measurements and non-missing LVOT-G at rest. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. | 10 weeks | The Pharmacodynamics Analysis Set (PDS) included all participants who received at least 1 dose of IP and had a baseline and at least 1 post-baseline core laboratory echocardiography assessment including non-missing LVEF measurements and non-missing LVOT-G at rest. | mmHg | MEAN |
| SECONDARY | Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF | Day 1 to End of Study (EOS) (Week 14) | The Pharmacodynamics Analysis Set (PDS) included all participants who received at least 1 dose of IP and had a baseline and at least 1 post-baseline core laboratory echocardiography assessment including non-missing LVEF measurements and non-missing LVOT-G at rest. | percentage per ng/ML | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events (AEs) | Cohort 1 (oHCM) - Aficamten | 10 | Participants | ||
| Incidence of Adverse Events (AEs) | Cohort 1 (oHCM) - Placbo | 7 | Participants | ||
| Incidence of Adverse Events (AEs) | Cohort 2 (oHCM) - Aficamten | 11 | Participants | ||
| Incidence of Adverse Events (AEs) | Cohort 2 (oHCM) - Placebo | 4 | Participants | ||
| Incidence of Adverse Events (AEs) | Cohort 3 (oHCM) - Aficamten & Background Disopyramide | 9 | Participants | ||
| Incidence of Adverse Events (AEs) | Cohort 4 (nHCM) - Aficamten | 28 | Participants | ||
| Incidence of Left Ventricular Ejection Fraction (LVEF) < 50% | Cohort 1 (oHCM) - Aficamten | 0 | Participants | ||
| Incidence of Left Ventricular Ejection Fraction (LVEF) < 50% | Cohort 1 (oHCM) - Placebo | 0 | Participants | ||
| Incidence of Left Ventricular Ejection Fraction (LVEF) < 50% | Cohort 2 (oHCM) - Aficamten | 2 | Participants | ||
| Incidence of Left Ventricular Ejection Fraction (LVEF) < 50% | Cohort 2 (oHCM) - Placebo | 0 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (oHCM) - Aficamten | 14 | |
| Overall Study | STARTED | Cohort 1 (oHCM) - Placebo | 8 | |
| Overall Study | STARTED | Cohort 2 (oHCM) - Aficamten | 14 | |
| Overall Study | STARTED | Cohort 2 (oHCM) - Placebo | 6 | |
| Overall Study | STARTED | Cohort 3 (oHCM) - Aficamten & Background Disopyramide | 13 | |
| Overall Study | STARTED | Cohort 4 (nHCM) - Aficamten | 41 | |
| Overall Study | COMPLETED | Cohort 1 (oHCM) - Aficamten | 14 | |
| Overall Study | COMPLETED | Cohort 1 (oHCM) - Placebo | 6 | |
| Overall Study | COMPLETED | Cohort 2 (oHCM) - Aficamten | 14 | |
| Overall Study | COMPLETED | Cohort 2 (oHCM) - Placebo | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events582
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 | Headache | Nervous system disorders | Cohort 1 (oHCM) - Aficamten | 3 | 14 | |
| other | Headache | Nervous system disorders | Cohort 1 (oHCM) - Placebo | 3 | 7 | |
| other | Headache | Nervous system disorders | Cohort 2 (oHCM) - Aficamten | 0 | 14 | |
| other | Headache | Nervous system disorders | Cohort 2 (oHCM) - Placebo | 1 | 6 | |
| other | Headache | Nervous system disorders | Cohort 3 (oHCM) - Aficamten & Background Disopyramide | 2 | 13 | |
| other | Headache | Nervous system disorders | Cohort 4 (nHCM) - Aficamten | 1 | 41 | |
| other | Dizziness | Nervous system disorders | Cohort 1 (oHCM) - Aficamten | 3 | 14 | |
| other | Dizziness | Nervous system disorders | Cohort 1 (oHCM) - Placebo | 1 | 7 | |
| other | Dizziness | Nervous system disorders | Cohort 2 (oHCM) - Aficamten | 2 | 14 | |
| other | Dizziness | Nervous system disorders | Cohort 2 (oHCM) - Placebo | 0 | 6 |
1 to 10 of 582Source ClinicalTrials.gov
See all 582 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (oHCM) - Aficamten | 0 | 14 |
| Total, all-cause mortality | Cohort 1 (oHCM) - Placebo | 0 | 7 |
| Total, all-cause mortality | Cohort 2 (oHCM) - Aficamten | 0 | 14 |
| Total, all-cause mortality | Cohort 2 (oHCM) - Placebo | 0 | 6 |
| Total, all-cause mortality | Cohort 3 (oHCM) - Aficamten & Background Disopyramide | 0 | 13 |
| Total, all-cause mortality | Cohort 4 (nHCM) - Aficamten | 1 | 41 |
| Total, other adverse events | Cohort 1 (oHCM) - Aficamten | 10 | 14 |
| Total, other adverse events | Cohort 1 (oHCM) - Placebo | 7 | 7 |
| Total, other adverse events | Cohort 2 (oHCM) - Aficamten | 11 | 14 |
| Total, other adverse events | Cohort 2 (oHCM) - Placebo | 4 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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.
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.
GET https://conductscience.org/api/trials/v1/NCT04219826
GET https://conductscience.org/api/trials/v1/NCT04219826/results?page=2