Vericiguat for Breast Cancer-Related Heart Failure

Recruiting in Palo Alto (17 mi)

Overseen by Anthony Yu, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Nitrates, Phosphodiesterase inhibitors

Disqualifiers: Hypertrophic cardiomyopathy, Uncontrolled arrhythmia, Severe hepatic insufficiency, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use long-acting nitrates, NO donors, or phosphodiesterase inhibitors while participating.

How does the drug Vericiguat differ from other treatments for breast cancer-related heart failure?

Vericiguat is unique because it works by stimulating an enzyme called soluble guanylate cyclase, which helps relax blood vessels and improve blood flow, potentially offering a novel approach for heart failure related to breast cancer treatment, unlike traditional heart failure drugs that may not address this specific mechanism.

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Eligibility Criteria

This trial is for adults over 18 with biopsy-proven breast cancer and heart issues due to past cancer treatments. They must have a specific decrease in heart function, be able to do an exercise test, and use effective birth control if needed. People can't join if they have severe kidney, liver, lung diseases or other conditions that could interfere with the study.

Inclusion Criteria

My breast cancer diagnosis was confirmed through a biopsy.

I agree to use effective birth control during and for 30 days after the study.

I am 18 years old or older.

Exclusion Criteria

I am currently using or plan to use a phosphodiesterase inhibitor.

I do not have any major heart, lung, or mental health issues that prevent me from exercising.

I do not have severe kidney, liver, or lung problems, or any other condition that would stop me from completing the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vericiguat or optimal medical therapy for cancer therapy-related cardiac dysfunction

6 months

Regular titration visits for dose adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial tests whether adding Vericiguat to standard heart failure treatment helps improve heart function in breast cancer patients who've developed cardiac dysfunction from previous cancer therapy better than standard treatment alone.

Group I: Vericiguat plus optimal medical therapy Experimental Treatment 1 Intervention

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.

Group II: Optimal medical therapy Active Control 1 Intervention

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

Vericiguat is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verquvo for:

• Heart failure

🇪🇺 Approved in European Union as Verquvo for:

• Chronic heart failure with reduced ejection fraction

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, NY

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Merck Sharp & Dohme LLC Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of American and European guidelines for cardio-oncology of heart failure. [2023] Heart failure is a complex clinical syndrome, whose signs and symptoms are caused by functional or structural impairment of ventricular filling or ejection of blood. Due to the interaction among anticancer treatment, patients' cardiovascular background, including coexisting cardiovascular diseases and risk factors, and cancer itself, cancer patients develop heart failure. Some drugs for cancer treatment may cause heart failure directly through cardiotoxicity or indirectly through other mechanisms. Heart failure in turn may make patients lose effective anticancer treatment, thus affecting the prognosis of cancer. Some epidemiological and experimental evidence shows that there is a further interaction between cancer and heart failure. Here, we compared the cardio-oncology recommendations among heart failure patients of the recent 2022 American guidelines, 2021 European guidelines, and 2022 European guidelines. Each guideline acknowledges the role of multidisciplinary (cardio-oncology) discussion before and during scheduled anticancer therapy.

2. United States pubmed.ncbi.nlm.nih.gov

Effect of statin therapy on the risk for incident heart failure in patients with breast cancer receiving anthracycline chemotherapy: an observational clinical cohort study. [2012] The aim of this study was to evaluate the effect of continuous statin treatment on new-onset heart failure (HF) in patients with breast cancer receiving anthracycline-based chemotherapy.

3. United States pubmed.ncbi.nlm.nih.gov

Management of Advanced Heart Failure due to Cancer Therapy: the Present Role of Mechanical Circulatory Support and Cardiac Transplantation. [2020] Rapid improvement in antineoplastic therapy is increasing not only cancer survivorship but also the incidence of end-stage heart failure among breast and childhood cancer survivors. Anthracyclines and newer targeted therapies, including trastuzumab and tyrosine kinase inhibitors, are important agents implemented in clinical practice that carry cardiotoxic risk. While acute heart failure is often self-limited and reversible, delayed-onset heart failure significantly reduces survival. Extremes of age, renal dysfunction, pre-existing coronary artery disease, HER2 positivity, and multi-drug therapy are predictors of irreversible heart failure after chemotherapy. Left ventricular assist device (LVAD) implantation and cardiac transplantation can be performed safely in patients with end-stage heart failure (HF) from chemotherapy. However, co-existing right ventricular dysfunction, hepatic congestion, and increased risk of bleeding make LVAD therapy challenging and dependent on careful patient selection. Cardiac transplantation in patients with chemotherapy-induced heart failure can be performed with good 10-year survival, but requires 5 years of cancer freedom and post-transplant infections remain a problem. Improvements in LVAD therapy and the expanding role of the total artificial heart and other durable biventricular support devices will likely provide more reliable surgical options for the management of end-stage HF after chemotherapy.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of surveillance by echocardiography for cancer therapeutics-related cardiac dysfunction of patients with breast cancer. [2023] Cancer therapeutics-related cardiac dysfunction (CTRCD) affect the prognosis of patients with breast cancer. Echocardiographic surveillance of patients treated with anti-human epidermal growth factor receptor type 2 (HER2) antibodies has been recommended, but few reports have provided evidence on patients with breast cancer only. We aimed to evaluate the effectiveness of echocardiographic surveillance for breast cancer patients.

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of chemotherapy-associated cardiomyopathy. [2020] The number of cancer survivors is increasing, and cardiovascular events are a significant cause of morbidity and mortality in these patients. Preexisting cardiovascular conditions as well as the development of cancer therapeutics-related cardiac dysfunction (CTRCD), in particular left ventricular dysfunction and heart failure, limit the options for cancer therapies for these patients and contribute to reduced cancer survival.