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NCT05186818 (Aficamten in Obstructive Hypertrophic Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 21 Aug 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 27 Dec 2023 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
NCT05186818
Acronym
SEQUOIA-HCM
Drug Name
Aficamten (CK-3773274)
Drug MoA
cardiac myosin inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Human Patients
282
Sponsor
Cytokinetics
Phase
Phase 3

Prediction of , index 927

Prospective Prediction
Prediction Index
927
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to metoprolol succinate)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
128 days in advance
Readout Data Interpretation
primary endpoint met with 1.74/mL/kg/min placebo-adjusted pVO2 improvement superior to the previous best treatment metoprolol succinate; and all endpoints met with high statistical significance (p<0.0001) even for patients who have received background beta-blockers.
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, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
Phase
Phase 3
Status
Completed
Enrollment
282
Lead sponsor
Cytokinetics
Conditions
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Interventions
DRUG: Aficamten (5 mg, 10 mg, 15 mg, and 20 mg); DRUG: Placebo to match aficamten
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-02-01
Primary completion
2023-11-10
Completion
2023-12-18
Results first posted
2026-03-03
Primary outcomes
  • Change From Baseline in pVO2 at Week 24 (Baseline to Week 24)

NCT05186818 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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