CompletedNCT04219826REDWOOD-HCMUpdated Feb 24, 2026Results posted

Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy

A Phase 2 interventional study of CK-3773274 (5 - 15 mg) and CK-3773274 (10 - 30 mg) in Hypertrophic Cardiomyopathy (HCM), sponsored by Cytokinetics. Completed at 22 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Cytokinetics · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).

Read the detailed description

This was a Phase 2, multi-center, randomized, placebo-controlled, double-blind, dose-finding study in participants with symptomatic HCM. The study consisted of 4 cohorts. For Cohorts 1 and 2, participants with obstructive HCM (oHCM) and not receiving disopyramide were randomized 2:1 to active or placebo treatment and received up to 3 escalating doses of aficamten (5, 10, and 15 mg once daily in Cohort 1 and 10, 20, and 30 mg once daily in Cohort 2) or placebo based on site-read echocardiographic guidance. Cohort 3 consisted of participants with oHCM whose background HCM therapy included disopyramide. All participants in Cohort 3 received up to 3 escalating doses of aficamten (5, 10, and 15 mg once daily) based on echocardiographic guidance. Cohort 4 consisted of participants with non-obstructive HCM (nHCM) on standard of care background therapy. Cohort 4 participants received up to 3 doses of aficamten (5, 10, and 15 mg once daily), titrated based on site-read echocardiographic guidance.

In all 4 cohorts, treatment duration was 10 weeks with a 4-week follow-up period after the last dose.

Conditions studied

Hypertrophic Cardiomyopathy (HCM)

Browse trials for

Cardiomyopathy, Hypertrophic 347

Keywords

CK-3773274
CK-274
obstructive hypertrophic cardiomyopathy
oHCM
REDWOOD-HCM
non-obstructive hypertrophic cardiomyopathy
nHCM
hypertrophic cardiomyopathy
HCM
aficamten
CY 6021

In context

Cardiomyopathy, Hypertrophic

347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.

This study's enrollment of 96 is above the median of 59 across 171 interventional studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Cytokinetics is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females between 18 and 85 years of age at screening.
Body weight is ≥45 kg at screening.
Diagnosed with HCM per the following criteria:
- Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
- Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
Adequate acoustic windows for echocardiography.
For Cohorts 1, 2 and 3 has LVOT-G during screening as follows:
- Resting gradient ≥50 mmHg OR
- Resting gradient ≥30 mmHg and \<50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
For Cohort 4 has resting and post-Valsalva LVOT-G \< 30 mmHg at the time of screening
For Cohort 4 has elevated NT-proBNP > 300 pg/mL at the time of screening
LVEF ≥60% at screening.
New York Heart Association (NYHA) Class II or III at screening.
Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.
For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for >4 weeks prior to screening and anticipate remaining on the same medication regimen during the study.

Exclusion criteria

Exclusion Criteria

Aortic stenosis or fixed subaortic obstruction.
Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
History of LV systolic dysfunction (LVEF \<45%) at any time during their clinical course.
Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period (Cohorts 1, 2, and 3 only). Patients having undergone septal reduction therapy > 12 months prior to screening who remain symptomatic from nHCM, and who meet all other criteria for inclusion, may be enrolled in Cohort 4.
For Cohorts 1, 2 and 4: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. (For Cohort 3, use of disopyramide is required).
Has any ECG abnormality considered by the investigator to pose a risk to patient safety (eg, second degree atrioventricular block type II).
Paroxysmal atrial fibrillation or flutter documented during the screening period.
Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months).
History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
Has received prior treatment with CK-3773274 or mavacamten.
For Cohort 4: has any documented history of LVOT-G ≥ 30 mmHg at rest, with Valsalva, or with exercise (for subjects who have had prior septal reduction therapy, this exclusion criteria only applies to gradients detected following septal reduction therapy).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 96 participants (actual)

Study arms

Experimental
Cohort 1 (oHCM) - Aficamten
Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks
Drug: CK-3773274 (5 - 15 mg)
Placebo comparator
Cohort 1 (oHCM) - Placebo
Participants received placebo once daily for up to 10 weeks
Drug: Placebo for CK-3773274
Experimental
Cohort 2 (oHCM) - Aficamten
Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks
Drug: CK-3773274 (10 - 30 mg)
Placebo comparator
Cohort 2 (oHCM) - Placebo
Participants received placebo once daily for up to 10 weeks
Drug: Placebo for CK-3773274
Experimental
Cohort 3 (oHCM) - Aficamten & Background Disopyramide
Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide
Drug: CK-3773274 (5 - 15 mg)
Experimental
Cohort 4 (nHCM) - Aficamten
Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks
Drug: CK-3773274 (5 - 15 mg)

Interventions

DrugCK-3773274 (5 - 15 mg)
CK-3773274 tablets administered orally once daily
DrugCK-3773274 (10 - 30 mg)
CK-3773274 tablets administered orally once daily
DrugPlacebo for CK-3773274
Placebo administered orally once daily

What researchers measure

Primary outcomes

Incidence of Adverse Events (AEs)
Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.
Time frame: 14 weeks
Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%
Participant incidence of LVEF \< 50% as assessed by the core laboratory assessment.
Time frame: 14 weeks
Incidence of Serious Adverse Events (SAEs)
Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.
Time frame: 14 weeks

Secondary outcomes

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)
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)
Time frame: Baseline and 10 weeks
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G
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)
Time frame: Baseline and 10 Weeks
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose.
Dose response relationship on resting LVOT-G of CK-3773274 in participants with oHCM (Cohorts 1, 2, 3 only)
Time frame: Baseline and 10 Weeks
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose.
Dose response relationship of CK-3773274 on post-Valsalva LVOT-G in participants with symptomatic oHCM (Cohorts 1, 2, 3 only)
Time frame: 10 weeks
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF
Concentration-response relationship of CK-3773274 on LVEF over 10 weeks of treatment in participants with HCM
Time frame: Day 1 to End of Study (EOS) (Week 14)

Results

Posted Feb 24, 2026

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
Started	14	8	14	6	13	41
Completed	14	6	14	6	13	39
Not completed	0	2	0	0	0	2
Withdrew: Protocol violation	0	2	0	0	0	0
Withdrew: Withdrawal by subject	0	0	0	0	0	1
Withdrew: Death	0	0	0	0	0	1

Outcome measures

PrimaryIncidence of Adverse Events (AEs)

Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.

Time frame:: 14 weeks
Reported as:: Count of participants · Participants

Incidence of Adverse Events (AEs)
Participants	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placbo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
Incidence of Adverse Events (AEs)	10	7	11	4	9	28

PrimaryIncidence of Left Ventricular Ejection Fraction (LVEF) < 50%

Participant incidence of LVEF \< 50% as assessed by the core laboratory assessment.

Time frame:: 14 weeks
Reported as:: Count of participants · Participants

Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%
Participants	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%	0	0	2	0	0	3

PrimaryIncidence of Serious Adverse Events (SAEs)

Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.

Time frame:: 14 weeks
Reported as:: Count of participants · Participants

Incidence of Serious Adverse Events (SAEs)
Participants	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
Incidence of Serious Adverse Events (SAEs)	1	1	1	0	0	4

SecondarySlope 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)

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)

Time frame:: Baseline and 10 weeks
Reported as:: Least squares mean · mmHg per ng/ML

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)
mmHg per ng/ML	Cohort 1 (oHCM) - Aficamten	Cohort 2 (oHCM)	Cohort 3 (oHCM) - Aficamten & Background Disopyramide
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)	-0.1018 (-0.1394 to -0.0642)	-0.0173 (-0.0325 to -0.0021)	-0.0582 (-0.1029 to -0.0135)

SecondarySlope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G

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)

Time frame:: Baseline and 10 Weeks
Reported as:: Least squares mean · mmHg per ng/ML

Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G
mmHg per ng/ML	Cohort 1 (oHCM) - Aficamten	Cohort 2 (oHCM) - Aficamten	Cohort 3 (oHCM) - Aficamten & Background Disopyramide
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G	-0.0902 (-0.1391 to -0.0413)	-0.0538 (-0.0765 to -0.0310)	-0.1396 (-0.2144 to -0.0649)

SecondaryChange From Baseline in Resting LVOT-G Over Time as a Function of Dose.

Dose response relationship on resting LVOT-G of CK-3773274 in participants with oHCM (Cohorts 1, 2, 3 only)

Time frame:: Baseline and 10 Weeks
Reported as:: Mean · mmHg

Change From Baseline in Resting LVOT-G Over Time as a Function of Dose.
mmHg	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide
Placebo	—	-19.2 ± 30.3	—	-0.5 ± 11.5	—
5 mg QD	-23.8 ± 17.0	—	—	—	-16.0 ± 15.3
10 mg QD	-48.6 ± 31.1	—	-53.1 ± 38.9	—	-22.6 ± 14.3
15 mg QD	-45.5 ± 27.2	—	—	—	-39.5 ± 26.9
20 mg QD	—	—	-30.8 ± 27.7	—	—
30 mg QD	—	—	-3.1 ± NA	—	—

Statistical analysis

Cohort 1 (oHCM) - Aficamten vs Cohort 1 (oHCM) - Placebo · Slope: -2.35 · 90% CI -3.18 to -1.53
Cohort 2 (oHCM) - Aficamten vs Cohort 2 (oHCM) - Placebo · Slope: -0.45 · 90% CI -0.88 to -0.01
Cohort 1 (oHCM) - Aficamten · Ls mean difference: -25.4 · 90% CI -37.2 to -13.6This statistical analysis is reporting the least squares mean difference of the aficamten group vs. placebo in change from baseline in resting LVOT-G for Cohort 1
Cohort 2 (oHCM) - Aficamten vs Cohort 2 (oHCM) - Placebo · Ls mean difference: -24.7 · 90% CI -36.5 to -12.8This statistical analysis is reporting the least squares mean difference of the aficamten group vs. placebo in change from baseline in resting LVOT-G for Cohort 2

SecondaryChange From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose.

Dose response relationship of CK-3773274 on post-Valsalva LVOT-G in participants with symptomatic oHCM (Cohorts 1, 2, 3 only)

Time frame:: 10 weeks
Reported as:: Mean · mmHg

Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose.
mmHg	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide
Placebo	—	-10.5 ± 24.9	—	-3.0 ± 8.6	—
5 mg QD	-23.1 ± 28.7	—	—	—	-43.8 ± 40.6
10 mg QD	-35.1 ± 32.1	—	-66.7 ± 41.3	—	-13.5 ± 18.1
15 mg QD	-48.2 ± 20.4	—	—	—	-35.7 ± 44.1
20 mg QD	—	—	-38.4 ± 37.5	—	—
30 mg QD	—	—	18.6 ± NA	—	—

Statistical analysis

Cohort 1 (oHCM) - Aficamten vs Cohort 1 (oHCM) - Placebo · Mean difference (final values): -40.4 · 90% CI -50.9 to -30.0
Cohort 2 (oHCM) - Aficamten vs Cohort 2 (oHCM) - Placebo · Lsmean: -50.9 · 90% CI -61.3 to -40.5
Cohort 1 (oHCM) - Aficamten vs Cohort 1 (oHCM) - Placebo · Ls mean difference: -35.3 · 90% CI -50.9 to -19.7This statistical analysis is reporting the least squares mean difference of the aficamten group vs. placebo in change from baseline in post-Valsalva LVOT-G for Cohort 1
Cohort 2 (oHCM) - Aficamten vs Cohort 2 (oHCM) - Placebo · Ls mean difference: -45.8 · 90% CI -61.3 to -30.3This statistical analysis is reporting the least squares mean difference of the aficamten group vs. placebo in change from baseline in post-Valsalva LVOT-G for Cohort 2

SecondarySlope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF

Concentration-response relationship of CK-3773274 on LVEF over 10 weeks of treatment in participants with HCM

Time frame:: Day 1 to End of Study (EOS) (Week 14)
Reported as:: Least squares mean · percentage per ng/ML

Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF
percentage per ng/ML	Cohort 1 (oHCM) - Aficamten	Cohort 2 (oHCM) - Aficamten	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF	-0.0222 (-0.0331 to -0.0114)	-0.0200 (-0.0276 to -0.0124)	-0.0154 (-0.0285 to -0.0023)	-0.0105 (-0.0153 to -0.0056)

Statistical analysis

Cohort 1 (oHCM) - Aficamten · Slope: -0.02 · 90% CI -0.03 to -0.01
Cohort 2 (oHCM) - Aficamten · Slope: -0.02 · 90% CI -0.03 to -0.01
Cohort 3 (oHCM) - Aficamten & Background Disopyramide · Slope: -0.02 · 90% CI -0.03 to -0.00
Cohort 4 (nHCM) - Aficamten · Slope: -0.01 · 90% CI -0.02 to -0.01

Adverse events

Collected over Up to 14 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 (oHCM) - Aficamten	0/14 (0%)	1/14 (7.1%)	10/14 (71.4%)
Cohort 1 (oHCM) - Placebo	0/7 (0%)	1/7 (14.3%)	7/7 (100%)
Cohort 2 (oHCM) - Aficamten	0/14 (0%)	1/14 (7.1%)	11/14 (78.6%)
Cohort 2 (oHCM) - Placebo	0/6 (0%)	0/6 (0%)	4/6 (66.7%)
Cohort 3 (oHCM) - Aficamten & Background Disopyramide	0/13 (0%)	0/13 (0%)	9/13 (69.2%)
Cohort 4 (nHCM) - Aficamten	1/41 (2.4%)	4/41 (9.8%)	26/41 (63.4%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
HypotensionVascular disorders	0/14	1/7	0/14	0/6	0/13	0/41
Stress cardiomyopathyCardiac disorders	0/14	1/7	0/14	0/6	0/13	0/41
SyncopeNervous system disorders	0/14	1/7	0/14	0/6	0/13	0/41
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	0/14	1/7	0/14	0/6	0/13	0/41
Pulmonary oedemaRespiratory, thoracic and mediastinal disorders	0/14	1/7	0/14	0/6	0/13	0/41
Acute coronary syndromeCardiac disorders	0/14	0/7	1/14	0/6	0/13	0/41
Back painMusculoskeletal and connective tissue disorders	1/14	0/7	0/14	0/6	0/13	0/41
Atrial fibrillationCardiac disorders	0/14	0/7	0/14	0/6	0/13	1/41
Cardiac arrestCardiac disorders	0/14	0/7	0/14	0/6	0/13	1/41
Myasthenia gravisImmune system disorders	0/14	0/7	0/14	0/6	0/13	1/41

Most frequent other events

Showing 10 of 86

Most frequent other events
Event	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten
HeadacheNervous system disorders	3/14	3/7	0/14	1/6	2/13	1/41
Dry mouthGastrointestinal disorders	1/14	0/7	0/14	2/6	0/13	0/41
DizzinessNervous system disorders	3/14	1/7	2/14	0/6	0/13	4/41
FatigueGeneral disorders	1/14	1/7	0/14	0/6	1/13	7/41
NauseaGastrointestinal disorders	0/14	1/7	0/14	1/6	1/13	3/41
BursitisMusculoskeletal and connective tissue disorders	0/14	0/7	0/14	1/6	0/13	0/41
Dry eyeEye disorders	0/14	0/7	0/14	1/6	0/13	0/41
Weight increasedInvestigations	0/14	0/7	0/14	1/6	0/13	0/41
Seasonal allergyImmune system disorders	0/14	0/7	0/14	1/6	0/13	0/41
ArthralgiaMusculoskeletal and connective tissue disorders	0/14	0/7	0/14	0/6	2/13	0/41

Baseline characteristics

One participant in the placebo group was discontinued from the study prior to receiving treatment.

Age, Categorical
Age, Categorical(Participants)	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten	Total
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	8	4	9	6	9	28	64
>=65 years	6	3	5	0	4	13	31

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten	Total
Female	4	6	11	2	7	24	54
Male	10	1	3	4	6	17	41

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten	Total
Hispanic or Latino	0	0	0	0	1	2	3
Not Hispanic or Latino	14	7	14	6	12	39	92
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten	Total
American Indian or Alaska Native	0	0	0	0	0	1	1
Asian	0	0	0	0	1	2	3
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	0	0	1	1	8	10
White	14	7	14	5	11	27	78
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	3	3

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten	Total
United States	13	7	13	5	13	35	86
Spain	1	0	0	0	0	5	6
Italy	0	0	1	1	0	1	3

LVEF
LVEF(%)	Cohort 1 (oHCM) - Aficamten	Cohort 1 (oHCM) - Placebo	Cohort 2 (oHCM) - Aficamten	Cohort 2 (oHCM) - Placebo	Cohort 3 (oHCM) - Aficamten & Background Disopyramide	Cohort 4 (nHCM) - Aficamten	Total
Mean	73.2 ± 5.6	76.8 ± 6.7	75.4 ± 6.4	71.9 ± 4.5	74.2 ± 7.5	69.8 ± 7.2	72.4 ± 7.0

Study locations

22 sites

Cedar-Sinai Medical Center
Los Angeles, California 90048, United States
UCSF Medical Center
San Francisco, California 94143, United States
Northwestern University
Evanston, Illinois 60208, United States
Tufts Medical Center
Boston, Massachusetts 02111, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
Michigan Medicine - University of Michigan
Ann Arbor, Michigan 48109, United States
Washington University School of Medicine
St Louis, Missouri 63110, United States
New York University Langone Health Medical Center
New York, New York 10016, United States
Carolinas Medical Center
Charlotte, North Carolina 28203, United States
Duke Cardiology at Southpoint
Durham, North Carolina 27713, United States
Oregon Health and Science University
Portland, Oregon 97239, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania 19104, United States
UMPC Heart and Vascular Institute
Pittsburgh, Pennsylvania 15213, United States
UT Southwestern Medical Center
Dallas, Texas 75390, United States
Houston Methodist Hospital
Houston, Texas 77030, United States
Intermountain Medical Center
Murray, Utah 84107, United States
University of Virginia Health System
Charlottesville, Virginia 22903, United States
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Erasmus University Medical Center (Erasmus MC)
Rotterdam, Netherlands
Complejo Hospitalario Universitario A Coruña
A Coruña, 15003, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, Spain

References and documents

Publications

Masri A, Sherrid MV, Abraham TP, Choudhury L, Garcia-Pavia P, Kramer CM, Barriales-Villa R, Owens AT, Rader F, Nagueh SF, Olivotto I, Saberi S, Tower-Rader A, Wong TC, Coats CJ, Watkins H, Fifer MA, Solomon SD, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Sohn RL, Wohltman A, Maron MS; REDWOOD-HCM Investigators. Efficacy and Safety of Aficamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Results From the REDWOOD-HCM Trial, Cohort 4. J Card Fail. 2024 Nov;30(11):1439-1448. doi: 10.1016/j.cardfail.2024.02.020. Epub 2024 Mar 15. PubMed 38493832 ↗
Zampieri M, Argiro A, Marchi A, Berteotti M, Targetti M, Fornaro A, Tomberli A, Stefano P, Marchionni N, Olivotto I. Mavacamten, a Novel Therapeutic Strategy for Obstructive Hypertrophic Cardiomyopathy. Curr Cardiol Rep. 2021 Jun 3;23(7):79. doi: 10.1007/s11886-021-01508-0. PubMed 34081217 ↗

Study documents

Study protocol · Nov 9, 2021
Statistical analysis plan · Jan 11, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04219826
Lead sponsor: Cytokinetics
Responsible party: Sponsor
First posted: Jan 7, 2020
Start date: Jan 10, 2020
Primary completion: Feb 28, 2023
Completion: Feb 28, 2023
Results posted: Feb 24, 2026
Last update: Feb 24, 2026

Study contacts

Cytokinetics, MD

study director · Cytokinetics

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy

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