Vericiguat for Heart Failure

Overseen By William Cornwell

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must not be taking: Nitrates, PDE5 inhibitors, others

Disqualifiers: Low blood pressure, Uncontrolled arrhythmias, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called vericiguat (also known as Verquvo), already approved for heart failure, to assess its effects on heart function, blood pressure, and blood vessels during exercise. Participants will receive either vericiguat or a placebo for about three months to compare the effects. Individuals with heart failure symptoms, such as worsening congestion or increased medication needs, might be suitable for this study. As a Phase 4 trial, this research aims to understand how the FDA-approved treatment benefits more patients, offering valuable insights for potential participants.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking certain medications, such as long-acting nitrates, soluble guanylate cyclase stimulators, phosphodiesterase type 5 inhibitors, and some anticoagulants. If you are on these medications, you may need to stop them to participate.

What is the safety track record for this treatment?

Research has shown that vericiguat, a drug recently approved by the FDA for heart failure, is generally safe for patients. In a large study, 11.3% of patients taking vericiguat experienced low blood pressure with symptoms like dizziness, compared to 9.2% of patients who took a placebo. This indicates that while vericiguat is mostly well-tolerated, some patients might experience a drop in blood pressure. Overall, vericiguat has been shown to help people with heart failure live longer and avoid hospital stays. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Vericiguat is unique because it offers a new approach to treating heart failure by directly stimulating a key enzyme called soluble guanylate cyclase (sGC). Most treatments for heart failure, like beta-blockers and ACE inhibitors, focus on managing symptoms and reducing workload on the heart. Vericiguat, however, targets the underlying molecular pathways involved in heart failure, which might improve heart function more effectively. Researchers are excited because this novel mechanism can potentially lead to better outcomes for patients who haven't responded well to existing therapies.

What is the effectiveness track record for Vericiguat in treating heart failure?

Research has shown that vericiguat effectively treats heart failure. In this trial, participants will receive either vericiguat or a placebo. A large study found that patients taking vericiguat experienced fewer heart-related deaths and hospital visits compared to those on a placebo. Specifically, the risk of dying from heart problems or needing hospitalization was lower for those on vericiguat. Other studies have found that vericiguat improves heart function by reducing the amount of blood left in the heart after it pumps. Overall, vericiguat has been shown to help patients with heart failure live longer and avoid hospital stays. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for heart failure patients who've been hospitalized or had increased diuretic therapy recently. They must have elevated BNP levels, indicating heart stress, within the last 30 days.

Inclusion Criteria

elevated brain natriuretic peptide level (BNP) within 30 days of enrollment;

I was hospitalized for heart failure or needed more diuretics recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing to assess initial cardiovascular performance and vascular biology

1 week

1 visit (in-person)

Treatment

Participants are randomized to receive either vericiguat or placebo for about three months

12 weeks

Regular visits (in-person) for monitoring

Follow-up Testing

Participants return for follow-up testing to assess changes in cardiovascular performance and vascular biology

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vericiguat

Trial Overview

The study tests Vericiguat's effects on heart function during activity and its potential benefits for blood pressure and vascular health compared to a placebo over three months.

How Is the Trial Designed?

Group I: Intervention Active Control 1 Intervention

Participants will be administered the drug vericiguat

Group II: Control Placebo Group 1 Intervention

Participants will be administered a placebo

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

Approved in United States as Verquvo for:

• Heart failure

Approved in European Union as Verquvo for:

• Chronic heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

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 ...

Following completion of the VICTORIA trial, vericiguat was approved for the treatment of worsening heart failure with reduced ejection ...

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12415756/

The Role of Vericiguat in Heart Failure Therapy

Clinical studies have demonstrated that vericiguat reduces both left ventricular end-diastolic and end-systolic volumes, leading to improved ...

5.

escardio.org

escardio.org/The-ESC/Press-Office/Press-releases/Pooled-analysis-supports-the-benefits-of-vericiguat-across-a-broad-range-of-heart-failure-patients

Pooled analysis supports the benefits of vericiguat across a ...

Vericiguat reduced the risk of both cardiovascular mortality and HF hospitalisations, and also all-cause mortality across the trials. These ...

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 ...

There was no significant reduction in time to first HHF with vericiguat (HR: 0.95; 95% CI: 0.82-1.10; P = 0.509) (Figure 1A, Table 1). Open in Viewer. Figure 1 ...