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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04083339

Public ClinicalTrials.gov record NCT04083339. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 8:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04083339
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Applied Therapeutics, Inc.
Industry
Enrollment
675 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 20, 2019 (Actual)
Primary completion
Dec 2023 (Estimated)
Completion
Dec 2025 (Estimated)
Last update posted
Dec 8, 2022

2019 – 2025

United States locations

U.S. sites
28
U.S. states
12
U.S. cities
23
Facility City State ZIP Site status
Westside Medical Associates of Los Angeles Beverly Hills California 90211 —
University of California, San Diego (UCSD) La Jolla California 92093 —
Clinical Trials Research Lincoln California 95648 —
University of California - Irvine Medical Center Orange California 92868 —
Metabolic Institute of America Tarzana California 91356 —
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center Torrance California 90509 —
ALL Medical Research, LLC Cooper City Florida 33024 —
New Generation of Medical Research Hialeah Florida 33016 —
Broward Research Center Pembroke Pines Florida 33024 —
Progressive Medical Research Port Orange Florida 32127 —
UnityPoint Health - Methodist Hospital Peoria Illinois 61602 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Universty of Mississippi Medical Center Jackson Mississippi 39216 —
St. Louis Heart and Vascular Cardiology St Louis Missouri 63136 —
Chear Center LLC The Bronx New York 10455 —
Montefiore Medical Center The Bronx New York 10467 —
Cleveland Clinic Cleveland Ohio 44195 —
Remington Davis, Inc. Columbus Ohio 43215 —
South Oklahoma Heart Research Oklahoma City Oklahoma 73135 —
Mountain View Clinical Research - Greer Greer South Carolina 29651 —
Mountain View Clinical Research Greer South Carolina 29651 —
Holston Medical Group Kingsport Tennessee 37660 —
Dallas Diabetes Research Center Dallas Texas 75230 —
Southwest Family Medicine Associates Dallas Texas 75235 —
University of Texas Southwestern Dallas Texas 75390 —
Juno Research, LLC - Northwest Site Houston Texas 77040 —
Juno Research, LLC - Southwest Houston Site Houston Texas 77074 —
FMC Science Lampasas Texas 76550 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04083339, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 8, 2022 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04083339 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →