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
Sponsor study identifier
interventional
675
10 countries
79
Study Start
September 20, 2019
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2019
Actual (reported)September 10, 2019
Actual (reported)September 20, 2019
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Peak VO2 during cardio-pulmonary exercise test (CPET);
Changes in Peak VO2 during cardio-pulmonary exercise test (CPET) from baseline to approximately Month 15 (15-18 months). A CPET may be repeated at approximately Month 27 (27-30 months).
15 months after randomization]
Progression to overt heart failure (Stage C Heart Failure)
27 months after randomization
Changes in NT-proBNP
27 months after randomization
Changes in the modified Kansas City Cardiomyopathy Questionnaire (KCCQ) score
27 months after randomization
Worsening of diabetic cardiomyopathy
15 and 27 months after randomization
Changes in echocardiographic parameters
27 months after randomization
The total daily doses will be of 3g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 3g/day of AT-001 is capable of producing the maximum inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity).
The total daily doses will be of 2g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 2g/day of AT-001 is capable of producing a sufficient inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity).
AT-001 will be administered as 3 capsules twice daily, before breakfast and before dinner. At present AT001 is the sole name for the active substance. No INN/genetic name is available to date
Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211, United States
University of California, San Diego (UCSD)
La Jolla, California, 92093, United States
Clinical Trials Research
Lincoln, California, 95648, United States
University of California - Irvine Medical Center
Orange, California, 92868, United States
Metabolic Institute of America
Tarzana, California, 91356, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90509, United States
ALL Medical Research, LLC
Batista JL, Liu Y, Butler J, Del Prato S, Ezekowitz JA, Lam CSP, Marwick TH, Rosenstock J, Tang WHW, Perfetti R, Urbinati A, Zannad F, Ilonze O, Januzzi JL. Racial outcomes in patients with diabetic cardiomyopathy treated with an aldose reductase inhibitor: the ARISE-HF trial. Open Heart. 2026 Jul 31;13(2):e004312. doi: 10.1136/openhrt-2026-004312.
Blumer V, Januzzi JL Jr, Liu Y, Butler J, Ezekowitz JA, Perfetti R, Rosenstock J, Del Prato S, Tang WHW, Urbinati A, Zannad F, Lewis GD, Solomon SD, Hedge S, Ibrahim NE, Lam CSP. Sex Differences in Diabetic Cardiomyopathy and Treatment Response to AT-001: Insights From the ARISE-HF Study. JACC Heart Fail. 2026 Jan;14(1):102433. doi: 10.1016/j.jchf.2025.02.015. Epub 2025 May 8.
James L Januzzi, MD
Harvard Medical School (HMS and HSDM)
First Submitted
August 23, 2019
First Posted
September 10, 2019
Study Start
September 20, 2019
Actual (reported)Primary Completion
December 2023
Estimated (date passed)Cardiovascular Effects of COVID-19
Placebo capsules will be used as comparator
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Cooper City, Florida, 33024, United States
New Generation of Medical Research
Hialeah, Florida, 33016, United States
Broward Research Center
Pembroke Pines, Florida, 33024, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
UnityPoint Health - Methodist Hospital
Peoria, Illinois, 61602, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Universty of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
St. Louis Heart and Vascular Cardiology
St Louis, Missouri, 63136, United States
Chear Center LLC
The Bronx, New York, 10455, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Remington Davis, Inc.
Columbus, Ohio, 43215, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
Mountain View Clinical Research - Greer
Greer, South Carolina, 29651, United States
Mountain View Clinical Research
Greer, South Carolina, 29651, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Juno Research, LLC - Northwest Site
Houston, Texas, 77040, United States
Juno Research, LLC - Southwest Houston Site
Houston, Texas, 77074, United States
FMC Science
Lampasas, Texas, 76550, United States
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
CORE Research Group Pty. Ltd.
Milton, Queensland, 4064, Australia
AusTrials
Taringa, Queensland, 4068, Australia
University of Tasmania at Hobart
Hobart, Tasmania, 7001, Australia
Barwon Health-University Hospital Geelong
Geelong, Victoria, 3220, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004, Australia
C-Endo - Endocrinology Centre
Calgary, Alberta, T2V 4J2, Canada
BC Diabetes
Vancouver, British Columbia, V5Y 3W2, Canada
LMC Diabetes & Endocrinology Ltd. - Brampton
Brampton, Ontario, L6S 0C6, Canada
LMC Diabetes & Endocrinology Ltd. - Thornhill
Concord, Ontario, L4K 4M2, Canada
LMC Diabetes & Endocrinology Ltd. - Etobicoke
Etobicoke, Ontario, M9R 4E1, Canada
Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University
London, Ontario, N6G 2M1, Canada
LMC Diabetes & Endocrinology Ltd. - Toronto
Toronto, Ontario, M4G 3E8, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, G1V 4G5, Canada
Edumed s.r.o.
Jaroměř, 55101, Czechia
Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice
Pardubice, 532 03, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition
Bondy, 93140, France
CHU Henri Mondor
Créteil, 94000, France
CHU de Nantes, Clinique d'Endocrinologie
Nantes, 44093, France
Centre Hospitalier de Valenciennes
Valenciennes, 59322, France
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Brandenburg, 15236, Germany
Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Cardiologicum Pirna und Dresden
Dresden, Saxony, 01277, Germany
Klinische Forschung Berlin GbR
Berlin, 10787, Germany
ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH
Elsterwerda, 04910, Germany
Erik Yee Mun George Fung
Shatin, Hong Kong
Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics
Shatin, Hong Kong
Centrum Chorob Serca w USK
Wroclaw, Borowska, 50-556, Poland
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, 15-435, Poland
Topolowa MEDICENTER Mrózek & wspólnicy sp.j.
Krakow, 31-506, Poland
Centrum Twojego Zdrowia
Krakow, 31-526, Poland
ETG Lodz
Lodz, 90-302, Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, 61-655, Poland
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika
Radom, 26-600, Poland
Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK
Rzeszów, 35-005, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
Wroclaw, 50-981, Poland
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Abente y Lago (Complejo Universitario de la Coruña)
A Coruña, 15001, Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
CPS Research
Glasgow, G20 0XA, United Kingdom
Glenfield hospital
Leicester, LE3 9QP, United Kingdom
Barts and The London School of Medicine & Dentistry
London, EC1M 6BQ, United Kingdom
Wythenshawe Hospital
Manchester, M23 9Lt, United Kingdom
Siddiqi TJ, Liu Y, Zannad F, Tang WHW, Solomon S, Rosenstock J, Perfetti R, Marwick TH, Lewis GD, Lam CSP, Ibrahim NE, Ezekowitz J, Del Prato S, Butler J, Januzzi JL. Health status in stage B heart failure from diabetic cardiomyopathy baseline results from ARISE-HF. J Diabetes Complications. 2025 Jul;39(7):109059. doi: 10.1016/j.jdiacomp.2025.109059. Epub 2025 Apr 25.
Tang WHW, Liu Y, Butler J, Del Prato S, Ezekowitz JA, Ibrahim NE, Lam CSP, Marwick TH, Perfetti R, Rosenstock J, Solomon SD, Zannad F, Januzzi JL, Lewis GD. Impaired Exercise Capacity in High-Risk Diabetic Cardiomyopathy: The ARISE-HF Cardiopulmonary Exercise Testing Subanalysis. Circ Heart Fail. 2025 Mar;18(3):e012200. doi: 10.1161/CIRCHEARTFAILURE.124.012200. Epub 2025 Jan 30.
Marwick TH, Lam C, Liu Y, Del Prato S, Rosenstock J, Butler J, Ezekowitz J, Ibrahim NE, Tang WHW, Zannad F, Perfetti R, Januzzi JL. Echocardiographic phenotypes of diabetic myocardial disorder: evolution over 15 months follow-up in the ARISE-HF trial. Cardiovasc Diabetol. 2025 Jan 13;24(1):16. doi: 10.1186/s12933-024-02554-y.
Gouda P, Liu Y, Butler J, Del Prato S, Ibrahim NE, Lam CSP, Marwick T, Rosenstock J, Tang W, Zannad F, Januzzi J, Ezekowitz J. Relationship between NT-proBNP, echocardiographic abnormalities and functional status in patients with subclinical siabetic cardiomyopathy. Cardiovasc Diabetol. 2024 Aug 2;23(1):281. doi: 10.1186/s12933-024-02378-w.
Batista JL, Liu Y, Butler J, Del Prato S, Ezekowitz JA, Lam CSP, Marwick TH, Rosenstock J, Tang WHW, Perfetti R, Urbinati A, Zannad F, Januzzi JL Jr, Ibrahim NE. Racial Differences in Diabetic Cardiomyopathy: The ARISE-HF Trial. J Am Coll Cardiol. 2024 Jul 16;84(3):233-243. doi: 10.1016/j.jacc.2024.04.053.
Januzzi JL Jr, Butler J, Del Prato S, Ezekowitz JA, Ibrahim NE, Lam CSP, Lewis GD, Marwick TH, Perfetti R, Rosenstock J, Solomon SD, Tang WHW, Zannad F. Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy. J Am Coll Cardiol. 2024 Jul 9;84(2):137-148. doi: 10.1016/j.jacc.2024.03.380. Epub 2024 Apr 8.
Januzzi JL, Del Prato S, Rosenstock J, Butler J, Ezekowitz J, Ibrahim NE, Lam CSP, Marwick T, Wilson Tang WH, Liu Y, Mohebi R, Urbinati A, Zannad F, Perfetti R. Characterizing diabetic cardiomyopathy: baseline results from the ARISE-HF trial. Cardiovasc Diabetol. 2024 Feb 1;23(1):49. doi: 10.1186/s12933-024-02135-z.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 8, 2022
Record last verified: 2022-12
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