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Clinical Trials in the UK / NCT06081894
Active, not recruiting Phase 3

A Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

NCT06081894 · tracked via the Priya Life Science UK tracker
Sponsor
Cytokinetics
Phase
Phase 3
Started
2023-08-31
Last updated
2026-08-05

Condition(s) studied

Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

AficamtenPlacebo

Aficamten: Oral Tablet

Placebo: Oral Tablet

Study summary

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Between 18-85 years of age * Body mass index \< 40 kg/m2 * Diagnosed with nHCM and has a screening echocardiogram with the following: * End-diastolic left ventricular (LV) wall thickness: * ≥ 15 mm in one or more myocardial segments OR * ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM AND * Resting LVOT-G \< 30 mmHg AND Valsalva LVOT-G \< 50 mmHg AND * LVEF ≥ 60% * Participants with a history of intracavitary obstruction are eligible. * NYHA class II or III * Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex * KCCQ-CSS score of ≤ 85 * NT-proBNP of: * NT-pro BNP ≥ 300 pg/mL or NT-proBNP ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR * For Black participants, an NT-pro BNP ≥ 225 pg/mL or NT-proBNP ≥ 675 pg/mL if in atrial fibrillation or atrial flutter Exclusion Criteria: * Significant valvular heart disease (per Investigator judgment) * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction * Moderate or severe mitral regurgitation * Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis) * Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction. * History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy * Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations) * Documented room air oxygen saturation reading \< 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension * History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening * History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control) * Screening diastolic blood pressure ≥ 100 mmHg * Received prior treatment with aficamten * Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening) * Undergone septal reduction therapy \< 6 months prior to screening * Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period * Paroxysmal or permanent atrial fibrillation is excluded only if: * rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to screening * rate control and anticoagulation have not been achieved for at least 3 months prior to screening.

Primary outcome measure(s)

Trial sites (180)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
UC San Diego Health - Sulpizio Cardiovascular Center La Jolla California
Keck Medical Center of USC (Outpatient Clinic) Los Angeles California
Cedars-Sinai Medical Center (Smidt Heart Institute) Los Angeles California
UCLA Medical Center Cardiovascular Clinic Los Angeles California
University of California San Francisco San Francisco California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
Yale New Haven Hospital New Haven Connecticut
MedStar Washington Hospital Center Washington D.C. District of Columbia
Holy Cross Medical Group - Cardiology Associates Fort Lauderdale Florida
Investigational Drug Services, AdventHealth Orlando Orlando Florida
Emory Clinic Atlanta Georgia
Piedmont Heart Institute (CPET) Fayetteville Georgia
The Queen's Medical Center-Punchbowl Honolulu Hawaii
Northwestern University Evanston Illinois
Ascension St. Vincent Indianapolis Indiana
University of Iowa Hospitals and Clinics Iowa City Iowa
The University of Kansas Medical Center Kansas City Kansas
MedStar Union Memorial Hospital Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Lahey Hospital & Medical Center Burlington Massachusetts
Michigan Medicine Ann Arbor Michigan
Henry Ford Hospital Detroit Michigan
M Health Fairview University of Minnesota Medical Center - East Bank Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Saint Luke's Hospital of Kansas City Kansas City Missouri
Morristown Medical Center Morristown New Jersey
Northwell Health North Shore University Hospital Manhasset New York
NYU Langone Health New York New York
Weill Cornell Medicine New York New York
Mount Sinai Hospital New York New York
Columbia University Medical Center/New York Presbyterian Hospital New York New York
Westchester Medical Center Valhalla New York
Sanger Heart & Vascular Institute - HCM Clinic Charlotte North Carolina
The Lindner Research Center at The Christ Hospital Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Cleveland Clinic Cleveland Ohio
Providence St. Vincent Medical Center Portland Oregon
Oregon Health & Science University Portland Oregon

+ 140 more sites — see the full list on the official registry below.

More Cytokinetics trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06081894 on ClinicalTrials.gov ↗ ← All trials in the UK