Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UC Irvine UCLA UCSD
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Diabetic Cardiomyopathies Type 2 Diabetes Aldose Reductase Inhibitor Stage B Heart Failure Stage C Heart Failure Cardiopulmonary Exercise Test Cardiomyopathies

Eligibility

You can join if…

Open to people ages 40 years and up

  • Type 2 Diabetes Mellitus
  • Echocardiographic demonstration of diabetic cardiomyopathy
  • Peak VO2 < 75% of predicted normal value based on age and gender

You CAN'T join if...

  • Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
  • Prior echocardiogrphic measurement of ejection fraction (EF) < 40%
  • Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke
  • Severe or moderate cardiac valve disease requiring intervention
  • Clinically significant arrhythmia
  • Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy
  • Blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at screening
  • HbA1c >8.5% at screening
  • Severe disease that would impact the performance of a cardio-pulmonary exercise test

Locations

  • University of California, San Diego (UCSD) accepting new patients
    La Jolla California 92093 United States
  • University of California - Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center accepting new patients
    Torrance California 90509 United States
  • Westside Medical Associates of Los Angeles accepting new patients
    Beverly Hills California 90211 United States
  • Metabolic Institute of America accepting new patients
    Tarzana California 91356 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Applied Therapeutics, Inc.
ID
NCT04083339
Phase
Phase 3
Study Type
Interventional
Last Updated