REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytokinetics

Criteria

Inclusion Criteria

• Males and females between 18 and 85 years of age at screening.

• Body weight is ≥45 kg at screening.

• Diagnosed with oHCM 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.

• 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

• 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

• 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.

• For Cohorts 1 and 2: 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).

• 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 is currently receiving mavacamten.