Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Pam Taub, MD
Photo of Pam Taub
Pam Taub

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

Lead Scientist at UCSD

  • Pam Taub, MD
    Pam R. Taub, MD, FACC, FASPC is Professor of Medicine at the UC San Diego School of Medicine in the Division of Cardiovascular Medicine. She is the Founding Director of the Step Family Foundation Cardiac Rehabilitation and Wellness Center. Dr. Taub was responsible for all aspects of creating the center.

Details

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