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For patients randomized to vericiguat, a starting dose of 2.5mg will be initiated at the randomization visit. At pre-specified titration visits, subjects will be up-titrated to vericiguat 5mg and then to the target dose of vericiguat 10mg using titration criteria based on mean systolic blood pressure and evaluation for clinical symptoms. Vericiguat will be administered in the background of optimal medical therapy for cardiomyopathy/heart failure.

For patients randomized to the control group, optimal medical therapy for cardiomyopathy/heart failure will be instituted throughout the study period.

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.

Vericiguat

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

Optimal medical therapy

Anthony Yu, MD

Jennifer Liu, MD

Anthony Yu, MD, MS

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.

This is a single center, open-label, randomized controlled trial of vericiguat in adult patients with breast cancer and Cancer Therapy-Related Cardiac Dysfunction (CTRCD).

A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction

A Randomized Controlled Trial of the Soluble Guanylate Cyclase Stimulator Vericiguat in Patients With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction (ELEVATE)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

For the primary analysis, intervention effect will be evaluated by comparing differences in mean VO2peak changes from baseline to month 6 between the investigational and control groups using the analysis of covariance approach (ANCOVA).

assessed by the number of participants with a change in VO2peak ≥ 1.32 ml O2 • kg-1 • min-1 (technical error of CRF measurement) from baseline to month 6. A change in VO2peak ≥ 1.32 ml O2 • kg-1 • min-1 will be considered a response, whereas a change in VO2peak \< 1.32 ml O2 • kg-1 • min-1 will be considered a non-response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction	NCT05806138	Breast Cancer Cardiac Dysfunc...	Vericiguat Optimal medical...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction	NCT05806138	Breast Cancer Cardiac Dysfunc...	Vericiguat Optimal medical...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for vericiguat

Every month we try and update this database with for vericiguat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vericiguat

Every month we try and update this database with for vericiguat cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vericiguat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.