REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in HCM (REDWOOD-HCM)

STATUS

Recruiting
days left to enroll

5
participants needed

95
sponsor

Cytokinetics

Updated on 6 April 2022

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Summary

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

Details

Condition	Hypertrophic Cardiomyopathy (HCM)
Treatment	CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg), Placebo for CK-3773274
Clinical Study Identifier	NCT04219826
Sponsor	Cytokinetics
Last Modified on	6 April 2022

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Eligibility		Yes	No	Not Sure
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
	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
	LVEF ≥60% at screening
	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
	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
	Paroxysmal atrial fibrillation or flutter documented during the screening period
	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)
	History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
	Has any ECG abnormality considered by the investigator to pose a risk to patient safety (eg, second degree atrioventricular block type II)
	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)
	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)

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REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in HCM (REDWOOD-HCM)