Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

Diabetic Cardiomyopathies Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

Clinical Trial Description

The study consists of two consecutive parts: Part A and Part B. Part A will evaluate the safety and efficacy of two doses of AT-001 vs placebo. The primary objective of Part A is to demonstrate that AT-001 improves or prevents the decline of functional capacity in patients with Diabetic Cardiomyopathy. Part B is an extension of at least 12 months that will evaluate the safety and efficacy of chronic administration of AT-001 vs placebo in the same patients who had previously been evaluated in Part A. Assessments in Part B will include safety endpoints and exploratory clinical efficacy endpoints, i.e. death and hospitalization due to a cardiac event. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetic Cardiomyopathies

• NCT number: NCT04083339
• Study type: Interventional
• Source: Applied Therapeutics, Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 20, 2019
• Completion date: December 2025