Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Condition(s) studied
Investigational drug(s) / intervention(s)
Aficamten (5 - 20 mg): Aficamten tablets, 5-20 mg daily, administered orally. Participants may continue on Aficamten until end of treatment criteria defined in the protocol is met.
Study summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Eligibility
Primary outcome measure(s)
- Incidence of adverse events observed during dosing of aficamten in patients with HCM — Baseline to End of study, up to 5 years
Patient incidence of reported Adverse Events (AEs) - Incidence of serious adverse events observed during dosing of aficamten in patients with HCM — Baseline to End of study, up to 5 years
Patient incidence of reported Serious Adverse Events (SAEs) - Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM — Baseline to End of study, up to 5 years
Patient incidence of reported LVEF \<50%
Trial sites (141)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Alaska Heart and Vascular Institute | Anchorage | Alaska | |
| Mayo Clinic Building - Phoenix | Phoenix | Arizona | |
| UC San Diego Health - Sulpizio Cardiovascular Center | La Jolla | California | |
| Cedar-Sinai Medical Center | Los Angeles | California | |
| Cedars-Sinai Medical Center (Smidt Heart Institute) | Los Angeles | California | |
| UCLA Health System - UCLA Cardiovascular Center | Los Angeles | California | |
| UCSF Medical Center | San Francisco | California | |
| Yale New Haven Hospital | New Haven | Connecticut | |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | |
| Holy Cross Hospital / Cardiology Associates | Fort Lauderdale | Florida | |
| Emory Clinic | Atlanta | Georgia | |
| Piedmont Fayette Hospital | Fayetteville | Georgia | |
| The Queen's Medical Center | Honolulu | Hawaii | |
| Northwestern University | Chicago | Illinois | |
| The University of Iowa Hospitals & Clinics | Iowa City | Iowa | |
| The University of Kansas Medical Center | Kansas City | Kansas | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | |
| Michigan Medicine - University of Michigan | Ann Arbor | Michigan | |
| University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center) | Ann Arbor | Michigan | |
| Henry Ford Hospital | Detroit | Michigan | |
| University of Minnesota | 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, Atrium Health | Charlotte | North Carolina | |
| Duke Cardiology at Southpoint | Durham | North Carolina | |
| The Linder Research Center at The Christ Hospital | Cincinnati | Ohio | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Cleveland Clinic | Cleveland | Ohio | |
| Ascension St. John Clinical Research Institute | Tulsa | Oklahoma | |
| Providence St. Vincent Medical Center | Portland | Oregon |
+ 101 more sites — see the full list on the official registry below.
More Cytokinetics trials in Australia
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 NCT04848506 on ClinicalTrials.gov ↗ ← All trials in Australia