Trials Sponsors Conditions Drugs Pricing

Conditions

Symptomatic hypertrophic cardiomyopathy (HCM)Symptomatic Hypertrophic Cardiomyopathy (HCM)

Keywords

Obstructive Hypertrophic CardiomyopathyoHCMCK-3773274CK-274Non obstructive hypertrophic cardiomyopathynHCMHCMHypertrophic cardiomyopathyAficamtenREDWOOD-OLECY 6022FOREST-HCMForest

Outcome Measures

Primary Outcomes (3)

Incidence of adverse events observed during dosing of aficamten in patients with HCM
Patient incidence of reported Adverse Events (AEs)
Baseline to End of study, up to 5 years
Incidence of serious adverse events observed during dosing of aficamten in patients with HCM
Patient incidence of reported Serious Adverse Events (SAEs)
Baseline to End of study, up to 5 years
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM
Patient incidence of reported LVEF \<50%
Baseline to End of study, up to 5 years

Study Arms (1)

Aficamten

EXPERIMENTAL

Participants in this arm take aficamten starting at the lowest prespecified dose and titrating up to their individual maximum tolerated dose. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic. After Week 48, the visits can be yearly if participants meet criteria.

Drug: Aficamten (5 - 20 mg)

Interventions

Aficamten (5 - 20 mg)Drug

Aficamten tablets, 5-20 mg daily, administered orally. Participants may continue on Aficamten until end of treatment criteria defined in the protocol is met.

Aficamten

AficamtenType not reported

Aficamten

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Aficamten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry record
Formulated product
Aficamten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry record
Formulated product
Aficamten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry record
Formulated product
Aficamten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Aficamten
Named ingredient: aficamten
View registry record
Aficamten
Named ingredient: aficamten
View registry record
Aficamten
Named ingredient: aficamten
View registry record
Aficamten
Named ingredient: aficamten
View registry record

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Completion of a Cytokinetics trial investigating aficamten
LVEF ≥ 55% at the Screening Visit

You may not qualify if:

Sponsors & Collaborators

Cytokinetics Inc.
Industrylead
Cytokinetics
Industrylead

Study Sites (141)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Alaska Heart and Vascular Institute

Anchorage, Alaska, 99508, United States

Mayo Clinic Building - Phoenix

Phoenix, Arizona, 85054, United States

UC San Diego Health - Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

Cedars-Sinai Medical Center (Smidt Heart Institute)

Los Angeles, California, 90048, United States

UCLA Health System - UCLA Cardiovascular Center

Related Publications (4)

Chen ML, Hodovan J, Masri A, Liu V, Kim MO, Melloni C, Jacoby DL, Heitner SB, Abraham TP. Aficamten is associated with improvements in cardiac mechanics in obstructive hypertrophic cardiomyopathy: Results from FOREST-HCM. Prog Cardiovasc Dis. 2026 Aug 25:S0033-0620(26)00098-8. doi: 10.1016/j.pcad.2026.08.013. Online ahead of print.
PMID: 42641848DERIVED
Saberi S, Abraham TP, Choudhury L, Barriales-Villa R, Elliott PM, Nassif ME, Oreziak A, Owens AT, Tower-Rader A, Rader F, Garcia-Pavia P, Olivotto I, Coats CJ, Fifer MA, Sherrid MV, Solomon SD, Watkins H, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Melloni C, Meng L, Wei J, Maron MS, Masri A; FOREST-HCM Steering Committee and Investigators. Aficamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: 48-Week Results From FOREST-HCM. JACC Heart Fail. 2025 Aug;13(8):102496. doi: 10.1016/j.jchf.2025.03.040. Epub 2025 Jun 19.
PMID: 40540987

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

Cytokinetics, MD
Cytokinetics
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 19, 2021

Study Start

May 6, 2021

Actual (reported)

Primary Completion

March 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Aficamten

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (141)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Secondary Outcomes (12)

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Aficamten

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (141)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Secondary Outcomes (12)

Data Sharing

Source records

Locations