What side effects are associated with this type of intervention?

Common treatments for heart failure that involve direct stimulation of soluble guanylate cyclase (sGC) to increase cyclic guanosine monophosphate (cGMP) levels, such as Vericiguat, often have side effects including hypotension (low blood pressure), dizziness, and gastrointestinal issues like nausea. Other heart failure treatments, such as ACE inhibitors, beta-blockers, and diuretics, can also cause side effects like cough, fatigue, electrolyte imbalances, and renal dysfunction. It is important to monitor these side effects closely and discuss them with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Vericiguat, a soluble guanylate cyclase (sGC) stimulator, is designed to increase cyclic guanosine monophosphate (cGMP) levels, which can improve vascular function and reduce inflammation. Another drug in this category is Riociguat, which has been approved for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). These drugs work by enhancing the nitric oxide (NO) signaling pathway, leading to vasodilation and improved blood flow. While Vericiguat is specifically being studied for its effects on heart failure, other treatments for heart failure include ACE inhibitors, beta-blockers, and diuretics, which work through different mechanisms to manage symptoms and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Vericiguat for heart failure patients include Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors like Empagliflozin and Canagliflozin, which have shown cardiovascular benefits and reduced heart failure hospitalizations. Another alternative is the use of Glucagon-Like Peptide-1 (GLP-1) receptor agonists such as Semaglutide and Liraglutide, which have demonstrated cardiovascular benefits in patients with type 2 diabetes and may offer similar benefits in heart failure. These therapies target different mechanisms but have shown promise in improving cardiovascular outcomes.

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sGC Stimulator

Vericiguat for Heart Failure

Q: What is the mechanism of action of this treatment?

Heart failure treatments often aim to improve cardiac function and reduce symptoms by targeting various pathways. Vericiguat, for example, directly stimulates soluble guanylate cyclase (sGC) to increase levels of cyclic guanosine monophosphate (cGMP), which helps relax blood vessels, reduce heart workload, and improve blood flow. This mechanism is particularly important for heart failure patients as it addresses endothelial dysfunction and oxidative stress, common issues in heart failure. Other treatments include beta-blockers, which reduce heart rate and myocardial oxygen demand, and ACE inhibitors or ARBs, which lower blood pressure and decrease the heart's workload by inhibiting the renin-angiotensin-aldosterone system. These treatments collectively help manage symptoms, improve quality of life, and reduce hospitalizations for heart failure patients.

Phase 4

Waitlist Available

Led By Josef Stehlik, M.D, M.P.H.

Research Sponsored by Josef Stehlik

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of chronic symptomatic HF (ACC/AHA Class C) and New York Heart Association (NYHA) Class II or III symptoms at the time of enrollment

Standard guideline-directed HF therapy

Must not have

Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat

Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial tests Vericiguat, a pill that helps improve heart and blood vessel function, in patients with heart failure who still have symptoms despite other treatments. The medication works by improving blood vessel function and reducing inflammation. Vericiguat is a new type of medication that has shown promise in helping patients with worsening chronic heart failure.

Who is the study for?

This trial is for adults with chronic heart failure, specifically those with reduced heart function (LVEF ≤45%) and symptoms of moderate severity. Participants must be on standard heart failure treatments, have stable blood pressure, and agree to contraception if they can become pregnant. Excluded are individuals on certain other heart medications, those with severe kidney issues or on dialysis, pregnant or breastfeeding women, and anyone allergic to sGC stimulators.

What is being tested?

The study tests Vericiguat's effects on peripheral vascular function in the context of inflammation and patient health status in heart failure patients. It compares Vericiguat against a placebo to see if it improves blood vessel function and reduces inflammation markers in patients likely to benefit from this treatment approach.

What are the potential side effects?

While specific side effects for Vericiguat aren't listed here, similar drugs often cause dizziness due to low blood pressure, headaches, nausea or upset stomach. There may also be risks of increased levels of an enzyme that could lead to liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic heart failure with moderate to severe symptoms.

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I am following standard treatment for heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using or plan to use a medication like riociguat.

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My kidney function is very low or I am on chronic dialysis.

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I am using or plan to use medication that includes nitrates or nitric oxide donors.

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I am currently using or plan to use medication like Viagra.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Flow-Mediated Dilation (FMD)

Secondary study objectives

Inflammatory Biomarkers serum Interleukin-1β (IL-1β)

Inflammatory Biomarkers serum Interleukin-6 (IL-6)

Kansas City Cardiomyopathy Questionnaire-12(KCCQ12)

+2 more

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534

15%

Hypotension

Dizziness

Anaemia

Cardiac failure

Nasopharyngitis

Dyspnoea

Diarrhoea

Pneumonia

Hyperkalaemia

Acute kidney injury

Chronic kidney disease

Syncope

Chronic obstructive pulmonary disease

Renal failure

Gastroenteritis

Ventricular tachycardia

Sepsis

Cardiac failure congestive

Cellulitis

Atrial fibrillation

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Vericiguat

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VericiguatExperimental Treatment1 Intervention

Study drug

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vericiguat

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Heart failure treatments often aim to improve cardiac function and reduce symptoms by targeting various pathways. Vericiguat, for example, directly stimulates soluble guanylate cyclase (sGC) to increase levels of cyclic guanosine monophosphate (cGMP), which helps relax blood vessels, reduce heart workload, and improve blood flow. This mechanism is particularly important for heart failure patients as it addresses endothelial dysfunction and oxidative stress, common issues in heart failure. Other treatments include beta-blockers, which reduce heart rate and myocardial oxygen demand, and ACE inhibitors or ARBs, which lower blood pressure and decrease the heart's workload by inhibiting the renin-angiotensin-aldosterone system. These treatments collectively help manage symptoms, improve quality of life, and reduce hospitalizations for heart failure patients.

Action of acetylcholine on regional myocardial work and metabolism in vivo: association with cyclic GMP.Impact of Mitochondrial Ca2+-Sensitive Potassium (mBKCa) Channels in Sildenafil-Induced Cardioprotection in Rats.Effects of cyclic GMP and its protein kinase on the contraction of ventricular myocytes from hearts after cardiopulmonary arrest.