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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT04219826
Date of registration: 03/01/2020
Prospective Registration: Yes
Primary sponsor: Cytokinetics
Public title: REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM REDWOOD-HCM
Scientific title: A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
Date of first enrolment: January 10, 2020
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04219826
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Italy Netherlands Spain United States
Contacts
Name:     Cytokinetics, MD
Address: 
Telephone: 650-624-2929
Email: medicalaffairs@cytokinetics.com
Affiliation: 
Name:     Study Director, MD
Address: 
Telephone:
Email:
Affiliation:  Cytokinetics
Key inclusion & exclusion 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.

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.

- Has been treated with disopyramide or antiarrhythmic drugs that have negative
inotropic activity within 4 weeks prior to screening.

- 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Obstructive Hypertrophic Cardiomyopathy
Intervention(s)
Drug: CK-3773274 (10 - 30 mg)
Drug: CK-3773274 (5 - 15 mg)
Drug: Placebo for CK-3773274
Primary Outcome(s)
Incidence of adverse events observed during dosing of CK-3773274 in patients with oHCM [Time Frame: 14 weeks]
Secondary Outcome(s)
Concentration-response relationship of CK-3773274 on the post-Valsalva left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment [Time Frame: 10 weeks]
Concentration-response relationship of CK-3773274 on the resting left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment [Time Frame: 10 weeks]
Dose response relationship of CK-3773274 in patients with oHCM at baseline [Time Frame: 10 weeks]
Dose response relationship of CK-3773274 in patients with oHCM post-Valsalva [Time Frame: 10 weeks]
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of during dosing of CK-3773274 in patients with oHCM [Time Frame: 14 weeks]
Incidence of serious adverse events observed during dosing of CK-3773274 in patients with oHCM [Time Frame: 14 weeks]
Plasma concentrations of CK-3773274 in patients with oHCM [Time Frame: Day 1 to End of Study (EOS) (Week 14)]
Secondary ID(s)
CY 6021
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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