Phase 3 study

By invitation Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status By invitation
Phase Phase 3
Sponsor Cytokinetics
Registry number NCT04848506
Started 6 May 2021 Today 16 October 2026 Estimated completion 1 March 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Flinders Medical Centre, Cardiology Research Bedford Park SA Status not stated
The Prince Charles Hospital Chermside QLD Status not stated
Fiona Stanley Hospital, AHF Unit Murdoch WA Status not stated

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years to 85 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 900

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Completion of a Cytokinetics trial investigating aficamten

* LVEF ≥ 55% at the Screening Visit

Exclusion Criteria:

* Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.

* Has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.

* Since completion of a previous trial of aficamten has:

* Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days

* Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)

* Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten

* History of implantable ICD placement within 30 days prior to screening.

Dates on the record

Started 6 May 2021
Estimated completion 1 March 2029
Registry last updated 13 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 13 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.