Aldose Reductase Inhibition for Stabilization of Exercise capacity in Heart Failure (ARISE-HF: A Multicentre, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure).
Trial objective: To demonstrate that AT-001 compared with Placebo decreases the worsening of performance on cardiopulmonary exercise test (CPET) in patients with Diabetic Cardiomyopathy (DdCM)/ Stage B Heart Failure (SBHF).Disease area: Diabetic Cardiomyopathy (DdCM)Status: Project in set upPI: Dr Manish SaxenaSponsor: Medpace UKFunder: Applied Therapeutics Inc
Diabetic cardiomyopathy (DbCM) is a type of heart disease that may progress to heart failure, a serious medical condition that can be debilitating and fatal if left untreated. The purpose of this study is to learn about the effects of the research medicine AT-001, to find the best dose, and to see how safe AT-001 is, compared to a placebo.
The study consists of 2 parts. Part A (screening through to month 27) and Part B (extension of at least 12 months after completion of Part A). Participants will begin the study in Part A and then enter Part B.
Part A will evaluate the safety and efficacy of two doses of AT-001 twice a day compared to placebo.Part B will continue to evaluate the safety and efficacy of AT-001 compared to placebo for a minimum of 12 months after completion of part A.
The estimated patient participation in the study will be approximately 30-33 months (including screening period of up to 8 weeks, a treatment period of approximately 27-30 months, and a 30-day post-treatment follow up period.
Ania Michalska, Senior Research NurseTel: +44(0) 20 7882 5665a.michalska@qmul.ac.uk