A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction
NCT05806138 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-07-31
Summary
The purpose of this study is to find out if adding vericiguat to standard treatment for cancer therapy related cardiac dysfunction (CTRCD) is more effective than standard treatment alone. The addition of vericiguat to the usual treatment could help improve cardiac function, but it could also cause side effects. This study will help researchers find out whether this different treatment is better, the same as, or worse than the usual approach.
Conditions
- Breast Cancer
- Cardiac Dysfunction
Interventions
- DRUG
-
Vericiguat
A starting dose of vericiguat 2.5 mg will be administered in-clinic at the Day 1 visit. Titration visits will occur on Days 14 and 28, with dose escalation to 5 mg and 10 mg.
- OTHER
-
Optimal medical therapy
All subjects will be followed by a cardiologist throughout the study period and will receive optimal medical therapy for cardiomyopathy/heart failure following the ACCF/AHA and ESC Guidelines for the Management of Heart Failure recommendations, applied individually at the discretion of the treating investigator and in line with individual tolerability. This includes medications such as ßblockers, angiotensin converting enzyme inhibitors(ACEI), angiotensin receptor/neprilysin inhibitor (ARNI), angiotensin receptor blockers (ARB), and mineralocorticoid antagonists
Sponsors & Collaborators
- collaborator INDUSTRY
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Anthony Yu, MD, MS · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-17
- Primary Completion
- 2028-07-17
- Completion
- 2028-07-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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