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NCT04083339 (AT-001 in Diabetic Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 2 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 8 Jan 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04083339
Acronym
ARISE-HF
Drug Name
AT-001
Drug MoA
Aldose Reductase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Diabetic Cardiomyopathy
Human Patients
675
Sponsor
Applied Therapeutics
Phase
Phase 3

Prediction of , index 1312

Prospective Prediction
Prediction Index
1312
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
67 days in advance
Readout Data Interpretation
primary efficacy endpoint peak VO2 not met.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Phase
Phase 3
Status
Active not recruiting
Enrollment
675
Lead sponsor
Applied Therapeutics, Inc.
Conditions
Diabetic Cardiomyopathies
Interventions
DRUG: AT-001; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-09-20
Primary completion
2023-12
Completion
2025-12
Primary outcomes
  • Peak VO2 during cardio-pulmonary exercise test (CPET); (15 months after randomization])

NCT04083339 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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