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

Study acronym: FOREST-HCM
StatusEnrolling by Invitation
PhasePhase 2/3
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2028 → Mar 2029
Primary endpoints added 1 → 3 primary endpoints
See other at-risk trials from Cytokinetics

Record History

The 50 most recent of 56 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 2028 to Mar 2029 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 129 → 141 locations
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints: 11 to 12
    • Publications: details revised at 4 of 4 entries
  2. Study sites: 120 to 129v55
  3. Study sites: 116 to 120v54
  4. Study sites: 112 to 116v53
  5. Study sites: 105 to 112v52
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 97 to 105v51
  2. Study sites: 95 to 97v50
  3. Study sites: 93 to 95v49
  4. Study sites: 90 to 93v48
  5. Study sites revised (90)v47
  6. Study sites: 89 to 90v46
  7. Study sites: 88 to 89v45
  8. Study sites: 85 to 88v44
  9. Study sites: 83 to 85v43
  10. Study sites: 81 to 83v42
  11. Study sites: 77 to 81v41
  12. Study sites: 76 to 77v40
  13. Study sites: 74 to 76v39
  14. Study sites: 72 to 74v38
  15. Secondary endpoints: 3 to 11v37
  16. Study sites: 71 to 72v36
  17. Study sites: 70 to 71v35
  18. Phase: Phase 2 to Phase 2/3v34 Show 6 more changesShow less
    • Enrollment target: 600 to 900
    • Primary and study completion dates: Mar 2026 to Mar 2028
    • Primary endpoint revised
    • Interventions: CK-3773274 (5 - 20 mg) (Drug) to Aficamten (5 - 20 mg) (Drug)
    • Secondary endpoints revised (3)
    • Eligibility criteria shortened, about 4 words
  19. Study sites: 68 to 70v33
  20. Study sites: 67 to 68v32
  21. Study sites: 66 to 67v31
  22. Study sites: 65 to 66v30
  23. Study title shortened, about 1 wordv29
  24. Study sites: 55 to 65v28
  25. Study sites: 47 to 55v27
  26. Study sites: 42 to 47v26
  27. Study sites: 25 to 42v25
  28. Enrollment target: 300 to 600
    • Eligibility criteria expanded, about 14 words
    v24
  29. Study sites: 22 to 25v23
  30. Study sites: 19 to 22v22
  31. Study sites: 18 to 19v21
  32. Study sites: 17 to 18v20
  33. Re-verified, no change to tracked fieldsv19
  34. Study sites: 14 to 17v18
  35. Study sites: 13 to 14v17
  36. Re-verified, no change to tracked fieldsv16
  37. Study sites: 12 to 13v15
  38. Study sites: 11 to 12v14
  39. Study sites: 9 to 11v13
  40. Study sites: 8 to 9v12
  41. Study sites: 7 to 8v11
  42. Enrollment target: 54 to 300v10 Show 7 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Enrolling by Invitation
    • Interventions: CK-3773274 (5 - 15 mg) (Drug) to CK-3773274 (5 - 20 mg) (Drug)
    • Eligibility criteria shortened, about 41 words
    • Secondary endpoints revised (3)
    • Site details revised at 7 of 7 sites
    • Study title expanded, about 1 word
  43. Study sites: 6 to 7v9
  44. Study sites: 5 to 6v8
  45. Study sites: 4 to 5v7
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cytokinetics
8 trials monitored
See 2 trials at risk
Heart Disease
8,814 trials monitored
See 428 trials at risk
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Trial Details
NCT Number NCT04848506
Lead Sponsor Cytokinetics
Conditions
(from sponsor)		 Symptomatic Hypertrophic Cardiomyopathy (HCM)
Related terms Cardiomyopathy, Hypertrophic
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov