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NCT05767346 (Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 27 Mar 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 13 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05767346
Acronym
MAPLE-HCM
Drug Name
Aficamten
Drug MoA
cardic myosin inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Human Patients
175
Sponsor
Cytokinetics
Phase
Phase 3

Prediction of , index 1220

Prospective Prediction
Prediction Index
1220
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in pVO2-CPET and NYHA moderately superior to metoprolol succinate)
Technical Prediction
SUCCESS (statistically significant clinical benefit in pVO2-CPET and NYHA compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
47 days in advance
Readout Data Interpretation
aficamten achieve statistically significant clinical benefit in pVO2 compared with metoprolol
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
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 Metoprolol in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Phase
Phase 3
Status
Completed
Enrollment
175
Lead sponsor
Cytokinetics
Conditions
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Interventions
DRUG: Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg); DRUG: Placebo to match aficamten; DRUG: Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg); DRUG: Placebo to match metoprolol succinate
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-06-20
Primary completion
2025-02-28
Completion
2025-03-28
Results first posted
2026-06-09
Primary outcomes
  • Change in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET) (Baseline to Week 24)

NCT05767346 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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