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Soluble Guanylate Cyclase Stimulator
Vericiguat for Heart Failure
Phase 2 & 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has biventricular physiology with a morphologic systemic left ventricle
Is currently receiving stable medical therapy for HF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Awards & highlights
Study Summary
This trial will compare Vericiguat to placebo to see if it reduces a heart-related protein, NTproBNP, in 16 weeks.
Who is the study for?
This trial is for pediatric patients with heart failure due to left ventricular systolic dysfunction who are on stable heart failure medication, have a systemic left ventricle, and an ejection fraction below 45%. Participants must not be pregnant or breastfeeding and use effective contraception if applicable. Exclusions include recent cardiovascular procedures, significant congenital cardiac malformations, severe pulmonary hypertension or kidney disease, liver disorders, clinical instability requiring intensive treatment, known allergies to vericiguat or similar drugs.Check my eligibility
What is being tested?
The study tests the effectiveness of Vericiguat (in suspension/tablet form) compared to a placebo in reducing NT-proBNP levels at Week 16 in children with heart failure. The primary goal is to see if Vericiguat can better decrease these biomarker levels indicative of heart stress than a non-active placebo.See study design
What are the potential side effects?
While specific side effects for pediatric use may not be fully established yet, potential side effects based on adult usage could include low blood pressure (hypotension), dizziness upon standing up (orthostatic hypotension), headache, nausea and fatigue. Allergic reactions are also possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart has two working chambers with the main pumping chamber being on the left.
Select...
I am on a stable treatment plan for heart failure.
Select...
I have a history of heart failure due to weak heart muscle pumping.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Secondary outcome measures
Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Change from baseline to Week 52 in log-transformed NT-proBNP
First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VericiguatExperimental Treatment2 Interventions
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks
Group II: PlaceboPlacebo Group2 Interventions
Placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,662 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,522 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been unstable with low blood pressure or needed strong heart or blood pressure medications recently.I recently had heart surgery to fix a birth defect.My heart has two working chambers with the main pumping chamber being on the left.I have a stomach or bile duct condition that affects how my body handles medicine.I need home oxygen for my lung condition or have interstitial lung disease.I have been diagnosed with or am currently experiencing myocarditis.I have a heart rhythm problem that isn't controlled by medication or devices.I am on a stable treatment plan for heart failure.I am allergic to vericiguat or similar medications.I have severe heart issues, possibly awaiting or have had a heart transplant, or I'm on continuous heart support.I have severe high blood pressure in the lungs.I have a history of heart failure due to weak heart muscle pumping.I have a condition where my heart muscle is abnormally thick or stiff.I am not pregnant or breastfeeding, and I either can't have children, use effective birth control, or have a negative pregnancy test.You have a certain type of heart defect called single ventricle disease or a specific heart structure called a morphologic systemic right ventricle.I am taking or plan to take medication for erectile dysfunction or heart/lung conditions.I have severe chronic kidney disease.I have a severe liver condition.I have a serious heart defect that hasn't been fully corrected by surgery.Your heart's pumping ability, called LVEF, is less than 45%.
Research Study Groups:
This trial has the following groups:- Group 1: Vericiguat
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility requirements for involvement in this experiment?
"Entrants to this trial must be between 28 days and 18 years of age, and have a diagnosis of heart failure. A total of 342 participants are being sought for the study."
Answered by AI
Is the minimum age requirement for participation in this medical trial below forty?
"Eligibility for this trial is limited to persons aged between 28 days and 18 years. There are 22 trials that accept applicants under the age of 18, while 722 studies permit seniors above 65 to participate."
Answered by AI
Are there still enrollments open for this research project?
"Data from clinicaltrials.gov indicates that this medical trial is actively enlisting participants, with an original post date of March 15th 2023 and a most recent refresher on February 23rd 2023."
Answered by AI
How many test subjects are participating in this clinical trial?
"Affirmative. Clinicaltrials.gov contains evidence that this experiment, which was initially advertised on March 15th 2023 and edited most recently on February 23rd 2023, is still in need of participants. As such, 342 patients are being recruited to a single site for the study's duration."
Answered by AI
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