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
ClinicalTrials.gov processed this data on December 7, 2022. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified December 2022 by Applied Therapeutics, Inc.
Sponsor
Applied Therapeutics, Inc.Information Provided by (Responsible Party)
Applied Therapeutics, Inc.Clinicaltrials.gov Identifier
NCT04083339Other Study ID Numbers: AT-001-2001
First Submitted: August 23, 2019
First Posted: September 10, 2019
Last Update Posted: December 8, 2022
Last Verified: December 2022
History of Changes
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Study Description
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.| Condition or Disease | Intervention/Treatment |
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Study Design
| Study Type | Interventional |
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| Anticipated Enrollment | 675 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | September 20, 2019 |
| Anticipated Primary Completion Date | December 2023 |
| Anticipated Study Completion Date | December 2025 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Peak VO2 during cardio-pulmonary exercise test (CPET); [15 months after randomization]] 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).
Secondary Outcome Measures
- Progression to overt heart failure (Stage C Heart Failure) [27 months after randomization] Defined by the occurrence of one of the following events: cardiovascular death, hospitalization for heart failure, urgent heart failure visit, new diagnosis of heart failure
- Changes in NT-proBNP [27 months after randomization] Changes in NT-proBNP may reflect worsening of cardiomyopathy over time
- Changes in the modified Kansas City Cardiomyopathy Questionnaire (KCCQ) score [27 months after randomization] Changes in the modified KCCQ may reflect deterioration of clinical status over time
Eligibility Criteria
| Ages Eligible for Study | 40 Years and Older (Adult, Older Adult) |
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| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
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Contacts and Locations
| Sponsors and Collaborators | Applied Therapeutics, Inc. |
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More Information
Additional Relevant MeSH Terms
- Cardiomyopathies
- Diabetic Cardiomyopathies
- Heart Diseases
- Cardiovascular Diseases
- Diabetes Complications
- Diabetes Mellitus
- Endocrine System Diseases