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Guanylate Cyclase Stimulator

Vericiguat for Breast Cancer-Related Heart Failure

Phase 2

Recruiting

Led By Anthony Yu, MD, MS

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven breast cancer (stage I-IV)

Age ≥ 18 years

Must not have

Concurrent or anticipated use of a phosphodiesterase inhibitor

Absolute contraindications to cardiopulmonary exercise testing including acute myocardial infarction, unstable angina, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, recurrent syncope, active endocarditis, acute myocarditis or pericarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, uncontrolled asthma, pulmonary edema, room air desaturation at rest ≤85%, respiratory failure, acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, mental impairment leading to inability to cooperate, current alcohol and/or drug abuse, any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if adding vericiguat to usual cancer therapy can improve cardiac function and if it causes side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Vericiguat may include low blood pressure, dizziness, headache or nausea. It might also interact with certain medications like nitrates or phosphodiesterase inhibitors which are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer diagnosis was confirmed through a biopsy.

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I am 18 years old or older.

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My heart function has worsened due to cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I do not have recent or severe heart problems.

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I am currently using or plan to use a long-acting nitrate or NO donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in CRF (measured by VO2peak)

Secondary study objectives

CRF response rate

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534

15%

Hypotension

Dizziness

Anaemia

Cardiac failure

Nasopharyngitis

Dyspnoea

Diarrhoea

Pneumonia

Hyperkalaemia

Acute kidney injury

Chronic kidney disease

Syncope

Chronic obstructive pulmonary disease

Renal failure

Gastroenteritis

Ventricular tachycardia

Sepsis

Cardiac failure congestive

Cellulitis

Atrial fibrillation

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Vericiguat

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vericiguat plus optimal medical therapyExperimental Treatment1 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 therapyActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vericiguat

2023

Completed Phase 4

~5080

0 / 8Eligibility criteria met