NCT04083339Active, not recruitingPhase 3
Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 675 (estimated)
- First submitted
- 23 Aug 2019
- Start date
- 20 Sept 2019
- Primary completion date
- Dec 2023
- Lead sponsor
- Applied Therapeutics, Inc.
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT04083339
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 675
- From 20 Sept 2019 to the primary completion date, Dec 2023
- 79 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
- Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke
- Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy
Other illness
- Severe or moderate cardiac valve disease requiring intervention
- Clinically significant arrhythmia
- Severe disease that would impact the performance of a cardio-pulmonary exercise test
Lab values
- Prior echocardiogrphic measurement of ejection fraction (EF) \< 40%
- HbA1c \>8.5% at screening
Other
- Blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic) at screening
Who the study is looking for
- Type 2 Diabetes Mellitus
- Diabetic cardiomyopathy
- Peak VO2 \< 75% of predicted normal value based on age and gender
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince Charles Hospital Coordinator of this site? Confirm its status | Chermside | Australia | Unknown status |
| Barwon Health - University Hospital Geelong Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| University of Tasmania at Hobart Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Baker Heart and Diabetes Institute Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Core Research Group Pty Ltd Coordinator of this site? Confirm its status | Milton | Australia | Unknown status |
| AusTrials Coordinator of this site? Confirm its status | Taringa | Australia | Unknown status |
| LMC Diabetes & Endocrinology Ltd. - Brampton Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| C-Endo - Endocrinology Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ecogene-21 Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| LMC Diabetes & Endocrinology Ltd. - Thornhill Coordinator of this site? Confirm its status | Concord | Canada | Unknown status |
| LMC Diabetes & Endocrinology Ltd. - Etobicoke Coordinator of this site? Confirm its status | Etobicoke | Canada | Unknown status |
| Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Institut universitaire de cardiologie et de pneumologie de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| LMC Diabetes & Endocrinology Ltd. - Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Diabetes Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| EDUMED s.r.o. Coordinator of this site? Confirm its status | Jaroměř | Czechia | Unknown status |
| Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice Coordinator of this site? Confirm its status | Pardubice | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Klinische Forschung Berlin GbR Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Cardiologicum Pirna und Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH Coordinator of this site? Confirm its status | Elsterwerda | Germany | Unknown status |
| Klinikum Frankfurt (Oder) GmbH Coordinator of this site? Confirm its status | Frankfurt (Oder) | Germany | Unknown status |
| Hospital Abente y Lago (Complejo Universitario de la Coruña) Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition Coordinator of this site? Confirm its status | Bondy | France | Unknown status |
| CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| CHU de Nantes, Clinique d'Endocrinologie Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier de Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Unknown status |
| Ninewells Hospital & Medical School Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| CPS Research Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Glenfield Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Barts and The London School of Medicine & Dentistry Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Erik Yee Mun George Fung Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Centrum Twojego Zdrowia Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Topolowa MEDICENTER Mrózek & wspólnicy sp.j. Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| ETG Lodz Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Praktyka Lekarska Ewa Krzyzagorska Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Coordinator of this site? Confirm its status | Radom | Poland | Unknown status |
| Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Centrum Chorob Serca w USK Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Westside Medical Associates of Los Angeles Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Remington Davis, Inc. Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| ALL Medical Research, LLC Coordinator of this site? Confirm its status | Cooper City | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Dallas Diabetes Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Southwest Family Medicine Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Mountain View Clinical Research Coordinator of this site? Confirm its status | Greer | United States | Unknown status |
| Mountain View Clinical Research - Greer Coordinator of this site? Confirm its status | Greer | United States | Unknown status |
| New Generation of Medical Research Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Juno Research, LLC - Southwest Houston Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Juno Research, LLC - Northwest Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Universty of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Holston Medical Group. Coordinator of this site? Confirm its status | Kingsport | United States | Unknown status |
| University of California San Diego (UCSD) Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| FMC Science Coordinator of this site? Confirm its status | Lampasas | United States | Unknown status |
| Clinical Trials Research Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| South Oklahoma Heart Research Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of California Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Broward Research Center Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| UnityPoint Health - Methodist Hospital Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| St. Louis Heart and Vascular Cardiology Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Metabolic Institute of America Coordinator of this site? Confirm its status | Tarzana | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| CHEAR Center LLC Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
Related publications
- Racial outcomes in patients with diabetic cardiomyopathy treated with an aldose reductase inhibitor: the ARISE-HF trial.Open Heart · 2026 · PMID 42538062
This page is information, not medical advice. Discuss any trial with your doctor.