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NCT06081894 (Aficamten in Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 16 Nov 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 4 May 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (moderately superior to mavacamten).

Clinical Trial

NCTID
NCT06081894
Acronym
ACACIA-HCM
Drug Name
Aficamten
Drug MoA
cardiac myosin inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (non-obstructive HCM)
Human Patients
500
Sponsor
Cytokinetics Incorporated
Phase
Phase 3

Prediction of , index 2094

Prospective Prediction
Prediction Index
2094
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit in KCCQ CSS numerically-to-slightly superior to metoprolol)
Technical Prediction
SUCCESS (statistically significant clinical benefit in KCCQ CSS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
169 days in advance
Readout Data Interpretation
aficamten achieved statistically significant 3.0 placebo-adjusted improvement in KCCQ-CSS (p= 0.021) and 0.67 placebo-adjusted improvement in pVO2 (p= 0.003), moderately superior mavacamten as prospectively predicated in No. 1959 (see add'l link below); safe and well-tolerated
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (moderately superior to mavacamten)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
Phase
Phase 3
Status
Active not recruiting
Enrollment
500
Lead sponsor
Cytokinetics
Conditions
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
Interventions
DRUG: Aficamten; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-08-31
Primary completion
2026-08-31
Completion
2026-11
Primary outcomes
  • Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) (Baseline to Week 36)
  • Change in pVO2 (Baseline to Week 36)

NCT06081894 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials