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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in CRF (measured by VO2peak)

Secondary outcome measures

CRF response rate

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534

15%

Hypotension

Dizziness

Anaemia

Cardiac failure

Dyspnoea

Nasopharyngitis

Diarrhoea

Pneumonia

Hyperkalaemia

Acute kidney injury

Syncope

Chronic kidney disease

Chronic obstructive pulmonary disease

Gastroenteritis

Ventricular tachycardia

Cardiac failure congestive

Sepsis

Renal failure

Cellulitis

Atrial fibrillation

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Vericiguat

Placebo

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

2016

Completed Phase 3

~5050

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,848 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,096 Total Patients Enrolled

25 Trials studying Heart Failure

20,269 Patients Enrolled for Heart Failure

Anthony Yu, MD, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Vericiguat (Guanylate Cyclase Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05806138 — Phase 2

Heart Failure Research Study Groups: Vericiguat plus optimal medical therapy, Optimal medical therapy

Heart Failure Clinical Trial 2023: Vericiguat Highlights & Side Effects. Trial Name: NCT05806138 — Phase 2

Vericiguat (Guanylate Cyclase Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05806138 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the administration sanctioned Vericiguat plus optimal medical therapy?

"Our team at Power gave Vericiguat a safety rating of 2 as there is some data suggesting its safety, yet no research that verifies the efficacy of this medication."

Answered by AI

Is this experiment still recruiting participants?

"According to clinicaltrials.gov, this experiment is no longer recruiting patients at the moment. The project was first made available on April 1st 2023 and most recently modified on March 28th 2023; however, there are over 2600 other studies enrolling participants now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05806138.