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sGC Stimulator

Vericiguat for Heart Failure

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 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
7%
Dizziness
7%
Anaemia
6%
Cardiac failure
5%
Nasopharyngitis
5%
Dyspnoea
5%
Diarrhoea
4%
Pneumonia
4%
Hyperkalaemia
3%
Acute kidney injury
2%
Chronic kidney disease
2%
Syncope
2%
Chronic obstructive pulmonary disease
1%
Ventricular tachycardia
1%
Gastroenteritis
1%
Sepsis
1%
Renal failure
1%
Cardiac failure congestive
1%
Cellulitis
1%
Atrial fibrillation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Who is running the clinical trial?

Josef StehlikLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Heart Failure
100 Patients Enrolled for Heart Failure
Merck Sharp & Dohme LLCIndustry Sponsor
3,981 Previous Clinical Trials
5,177,983 Total Patients Enrolled
25 Trials studying Heart Failure
20,593 Patients Enrolled for Heart Failure
Josef Stehlik, M.D, M.P.H.Principal InvestigatorUniversity of Utah Health Science Center & Veterans Affairs Salt Lake City Healthcare System

Media Library

Vericiguat (sGC Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05420012 — Phase 4
Heart Failure Research Study Groups: Vericiguat, Placebo
Heart Failure Clinical Trial 2023: Vericiguat Highlights & Side Effects. Trial Name: NCT05420012 — Phase 4
Vericiguat (sGC Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05420012 — Phase 4
~11 spots leftby Oct 2025