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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 belowSelect...
My breast cancer diagnosis was confirmed through a biopsy.
Select...
I am 18 years old or older.
Select...
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
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 • NCT0286153415%
Hypotension
7%
Dizziness
7%
Anaemia
6%
Cardiac failure
5%
Dyspnoea
5%
Nasopharyngitis
5%
Diarrhoea
4%
Pneumonia
4%
Hyperkalaemia
3%
Acute kidney injury
2%
Syncope
2%
Chronic kidney disease
2%
Chronic obstructive pulmonary disease
1%
Gastroenteritis
1%
Ventricular tachycardia
1%
Cardiac failure congestive
1%
Sepsis
1%
Renal failure
1%
Cellulitis
1%
Atrial fibrillation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,941 Previous Clinical Trials
588,866 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,908 Previous Clinical Trials
5,066,637 Total Patients Enrolled
26 Trials studying Heart Failure
20,611 Patients Enrolled for Heart Failure
Anthony Yu, MD, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I do not have recent or severe heart problems.My heart function has worsened due to cancer treatment.You need to be able to do a certain exercise test without any heart issues or problems with breathing.Your top blood pressure number is less than 90.I am currently using or plan to use a long-acting nitrate or NO donor.
Research Study Groups:
This trial has the following groups:- Group 1: Vericiguat plus optimal medical therapy
- Group 2: Optimal medical therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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