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sGC Stimulator
Vericiguat for Heart Failure
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
Study Summary
This trial will study whether the drug Vericiguat can help improve vascular function, inflammation, and health status in patients who have reduced nitric oxide availability.
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.Check my eligibility
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.See study design
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 belowSelect...
I have chronic heart failure with moderate to severe symptoms.
Select...
I am following standard treatment for heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Flow-Mediated Dilation (FMD)
Secondary outcome measures
Inflammatory Biomarkers serum Interleukin-1β (IL-1β)
Inflammatory Biomarkers serum Interleukin-6 (IL-6)
Kansas City Cardiomyopathy Questionnaire-12(KCCQ12)
+2 moreSide effects data
From 2019 Phase 3 trial • 5050 Patients • NCT0286153415%
Hypotension
7%
Dizziness
7%
Anaemia
6%
Cardiac failure
5%
Dyspnoea
5%
Nasopharyngitis
5%
Diarrhoea
4%
Pneumonia
4%
Hyperkalaemia
3%
Acute kidney injury
2%
Syncope
2%
Chronic kidney disease
2%
Chronic obstructive pulmonary disease
1%
Gastroenteritis
1%
Ventricular tachycardia
1%
Cardiac failure congestive
1%
Sepsis
1%
Renal failure
1%
Cellulitis
1%
Atrial fibrillation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vericiguat
Placebo
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
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
3,888 Previous Clinical Trials
5,055,033 Total Patients Enrolled
24 Trials studying Heart Failure
20,245 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or sensitive to any sGC stimulator.I am currently using or plan to use a medication like riociguat.I have chronic heart failure with moderate to severe symptoms.My heart's pumping ability is below 45%.My kidney function is very low or I am on chronic dialysis.I haven't started new heart failure medication or device therapy in the last 4 weeks.I am following standard treatment for heart failure.I am using or plan to use medication that includes nitrates or nitric oxide donors.I am currently using or plan to use medication like Viagra.Your blood pressure is too low.
Research Study Groups:
This trial has the following groups:- Group 1: Vericiguat
- Group 2: Placebo
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is this clinical trial presently taking in new participants?
"Unfortunately, per the data hosted on clinicaltrials.gov, this particular trial is not currently enrolling patients. It was first posted in early December of 2022 and most recently updated a few months ago. Nevertheless, there are still 1053 other trials looking for participants at this time."
Answered by AI
Has Vericiguat obtained governmental endorsement for use?
"As Vericiguat is an approved treatment, the safety rating of this medication was rated a 3 on our team's scale."
Answered by AI
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