Vericiguat for Heart Failure

Recruiting at 126 trial locations

Overseen By Toll Free Number

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Phosphodiesterase inhibitors, sGC stimulators

Disqualifiers: Unstable heart failure, Severe kidney disease, Hepatic disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

342 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called vericiguat for individuals with heart failure, a condition where the heart cannot pump blood effectively. Researchers aim to determine if vericiguat can lower a specific protein level linked to heart failure compared to a placebo (a sugar pill with no active ingredient) over 16 weeks. Suitable candidates for this trial have ongoing heart failure symptoms and have been on stable heart failure treatment.

As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to important advancements in heart failure treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you are on stable medical therapy for heart failure. You cannot use phosphodiesterase type 5 inhibitors or another sGC stimulator while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vericiguat is generally well-tolerated by people with heart failure. In studies, 11.3% of those taking vericiguat experienced symptoms of low blood pressure, compared to 9.2% of those on a placebo. This indicates that slightly more people on vericiguat felt symptoms from low blood pressure than those not taking the drug, but the difference is small.

Vericiguat has been tested in many patients, and serious side effects are rare. The FDA has already approved it for treating certain types of heart failure, indicating it is generally safe. Overall, the treatment appears promising and supports further use in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Vericiguat is unique because it targets a different pathway in heart failure management compared to traditional treatments like ACE inhibitors or beta-blockers. It works by stimulating soluble guanylate cyclase, which helps relax blood vessels and improve blood flow, potentially reducing the heart's workload. Researchers are excited about vericiguat because it offers a new option for patients who don't respond well to standard therapies, and it can be administered in both tablet and suspension forms, providing flexibility in treatment.

What evidence suggests that vericiguat might be an effective treatment for heart failure?

Research has shown that vericiguat can help people with heart failure. Various studies have demonstrated that vericiguat reduces hospital visits due to heart failure and lowers the risk of death from heart-related issues. For instance, one study found that 35.5% of patients taking vericiguat experienced serious heart problems, compared to 38.5% who did not. Another study showed that fewer people died from heart-related causes when taking vericiguat (9.6%) compared to those taking a placebo (11.3%). In this trial, participants will receive either vericiguat or a placebo to further evaluate its potential to improve heart health in people with heart failure. ^{1 2 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart has two working chambers with the main pumping chamber being on the left.

I am on a stable treatment plan for heart failure.

I have a history of heart failure due to weak heart muscle pumping.

Exclusion 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.

I have a stomach or bile duct condition that affects how my body handles medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Base Period

Participants receive vericiguat or placebo for 52 weeks to evaluate efficacy, safety, and pharmacokinetics

52 weeks

Regular visits at pre-dose, 2, 6, 16, 32, and 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension Period

Participants may opt into continuation of vericiguat treatment long-term

Up to 8 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo suspension
• Placebo tablet
• Vericiguat suspension
• Vericiguat tablet

Trial Overview

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.

How Is the Trial Designed?

Group I: Extension Period: Vericiguat Experimental Treatment 2 Interventions

Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period.

Group II: Base Period: Vericiguat Experimental Treatment 2 Interventions

Participants in the Base Period receive 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 III: Base Period: Placebo Placebo Group 2 Interventions

Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks.

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

Approved in United States as Verquvo for:

• Heart failure with reduced ejection fraction (HFrEF)

Approved in European Union as Verquvo for:

• Chronic heart failure with reduced ejection fraction (HFrEF)

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

Vericiguat was tested in a study involving patients with heart failure and reduced ejection fraction, showing significant efficacy in improving clinical outcomes compared to placebo.

The results suggest that vericiguat can be a beneficial treatment option for patients with this type of heart failure, potentially enhancing their quality of life and reducing hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vericiguat reduced a composite of CV death or HF hospitalization in patients with HF and reduced LVEF. Averbuch, T., Van Spall, HGC.[2020]

In the VICTORIA trial, vericiguat showed a significant reduction in heart failure hospitalizations or cardiovascular death, but the study found that both vericiguat and placebo led to similar improvements in left ventricular (LV) structure and function after 8 months, indicating that the benefits of vericiguat may not be solely due to reverse LV remodeling.

The study included 419 patients with heart failure with reduced ejection fraction (HFrEF) and demonstrated a trend towards a lower rate of the primary composite endpoint in the vericiguat group compared to placebo, suggesting potential clinical benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of vericiguat on left ventricular structure and function in patients with heart failure with reduced ejection fraction: The VICTORIA echocardiographic substudy. Pieske, B., Pieske-Kraigher, E., Lam, CSP., et al.[2023]

The phase 3 VICTORIA clinical trial showed that vericiguat significantly reduces the risk of cardiovascular death and heart failure hospitalizations in adults with chronic heart failure and an ejection fraction less than 45%.

Vericiguat provides a new treatment option for patients at risk of rehospitalization or those who do not tolerate existing heart failure therapies, demonstrating both safety and efficacy in managing chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vericiguat: A Novel Oral Soluble Guanylate Cyclase Stimulator for the Treatment of Heart Failure. Campbell, N., Kalabalik-Hoganson, J., Frey, K.[2022]

In a study involving 32 healthy male volunteers, the co-administration of vericiguat and sildenafil was found to be safe and well-tolerated, with only mild to moderate adverse events reported.

The combination resulted in a minimal decrease in seated blood pressure (≤ 5.4 mmHg) and did not significantly affect the pharmacokinetics of vericiguat, indicating that sildenafil can be safely used alongside vericiguat without major interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Influence of Sildenafil on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vericiguat in Healthy Adults. Boettcher, M., Nowotny, B., Krausche, R., et al.[2023]

Vericiguat is the first drug approved specifically for treating symptomatic patients with chronic heart failure with reduced ejection fraction (HFrEF), aimed at reducing the frequency of worsening heart failure episodes.

The article reviews the drug's design, efficacy, and ongoing clinical trials, highlighting its importance in a field with limited treatment options for patients experiencing repeated hospitalizations due to heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of vericiguat: The first soluble guanylate cyclase (sGC) stimulator launched for heart failure with reduced ejection fraction (HFrEF). Xia, J., Hui, N., Tian, L., et al.[2022]

In a study involving 74 patients with chronic coronary syndromes, vericiguat did not cause any clinically significant prolongation of the QT interval, which is important for heart rhythm safety.

The adverse effects of vericiguat were consistent with its intended action, and the study found no safety concerns, indicating it is a well-tolerated treatment option for patients with chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes. Böttcher, M., Düngen, HD., Corcea, V., et al.[2023]

In the phase III VICTORIA trial, vericiguat significantly reduced the risk of death from cardiovascular causes or first hospitalization for heart failure compared to placebo in adults with chronic heart failure with reduced ejection fraction (HFrEF).

Vericiguat was generally well tolerated, with hypotension being the most common treatment-related adverse event, indicating it is a safe and effective option for managing chronic HFrEF, especially after recent worsening events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vericiguat: A Review in Chronic Heart Failure with Reduced Ejection Fraction. Kang, C., Lamb, YN.[2022]

Citations

1.

merck.com

merck.com/news/merck-provides-new-results-for-verquvo-vericiguat-in-patients-with-chronic-heart-failure-and-reduced-ejection-fraction/

Merck Provides New Results for VERQUVO® (vericiguat) ...

For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO (9.6%) compared to placebo (11.3%) (HR 0.83; 95% CI ...

2.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(25)01682-4/fulltext

Vericiguat for patients with heart failure and reduced ...

Vericiguat reduced the risk of hospitalisation for heart failure and cardiovascular death in patients with HFrEF across a broad range of ...

3.

acc.org

acc.org/Latest-in-Cardiology/Clinical-Trials/2020/03/26/19/43/VICTORIA

Vericiguat Global Study in Subjects With Heart Failure With ...

The primary outcome, cardiovascular death or hospitalization for heart failure, occurred in 35.5% of the vericiguat group compared with 38.5% of ...

4.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK596771/

Clinical Review - Vericiguat (Verquvo) - NCBI - NIH

The proportion of HHF as the first event was lower in the vericiguat group (27.4%) compared with the placebo group (29.6%), whereas proportion of CV death was ...

5.

merckconnect.com

merckconnect.com/verquvo/efficacy/

Clinical Efficacy Data for VERQUVO® (vericiguat)

VERQUVO (vericiguat) plus background therapy was more effective than background therapy alone in reducing the risk of HF hospitalization and CV death.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41020754/

Blood pressure, safety and clinical efficacy of vericiguat in ...

Symptomatic hypotension occurred in 11.3% of vericiguat-treated patients compared with 9.2% of placebo-treated patients with an adjusted hazard ...

7.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1915928

Vericiguat in Patients with Heart Failure and Reduced ...

Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 ...

8.

jacc.org

jacc.org/doi/10.1016/j.jacc.2025.08.051

Effect of Vericiguat on Total Heart Failure Events in ...

The composite of all-cause death and overall worsening HF occurred in 917 participants (30.0%) in the vericiguat group and 1,004 participants (32.9%) in the ...