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Vericiguat for Heart Failure (VICTOR Trial)

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 40 months
Awards & highlights

VICTOR Trial Summary

This trial will test if vericiguat is better than placebo at reducing cardiovascular death or heart failure hospitalization in people with symptomatic HFrEF who are not recently hospitalized or using outpatient IV diuretics.

Who is the study for?
This trial is for adults with chronic heart failure who have a left ventricular ejection fraction of ≤40%, haven't been hospitalized for heart failure or needed IV diuretics recently, and are on stable heart failure medication. Women must not be pregnant, breastfeeding, or agree to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests whether Vericiguat can reduce the risk of cardiovascular death or hospitalization due to heart failure compared to a placebo in patients with reduced ejection fraction (HFrEF). Participants will either receive Vericiguat or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants may experience risks associated with taking Vericiguat such as changes in blood pressure, kidney function issues, dizziness, fatigue among others based on its action on the cardiovascular system.

VICTOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart's pumping ability is significantly reduced.

VICTOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 40 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Secondary outcome measures
Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs)
Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs)
Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAEs)
+5 more

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534
15%
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

VICTOR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VericiguatExperimental Treatment1 Intervention
Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily. The vericiguat dose will be titrated to 5 mg and to 10 mg.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive a starting matching placebo to vericiguat dose of 2.5 mg taken orally once daily. The matching placebo dose will be sham titrated to 5 mg and to 10 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vericiguat
2016
Completed Phase 3
~5050

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,576,606 Total Patients Enrolled
5 Trials studying Heart Failure
8,955 Patients Enrolled for Heart Failure
Merck Sharp & Dohme LLCLead Sponsor
3,896 Previous Clinical Trials
5,056,718 Total Patients Enrolled
24 Trials studying Heart Failure
14,269 Patients Enrolled for Heart Failure
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,782 Previous Clinical Trials
8,060,316 Total Patients Enrolled
6 Trials studying Heart Failure
829 Patients Enrolled for Heart Failure

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05093933 — Phase 3
Heart Failure Research Study Groups: Placebo, Vericiguat
Heart Failure Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05093933 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05093933 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being given this medication as part of the research?

"In order to carry out this research, 6000 subjects who meet the eligibility requirements are needed. The pharmaceutical company sponsoring the study, Merck Sharp & Dohme Corp., will be conducting the trial at multiple locations including Franciscan Physician Network - Indiana Heart Physicians ( Site 0087) in Indianapolis, Indiana and Accellacare - Wilmington ( Site 0090) in Wilmington, North carolina."

Answered by AI

Have patients undergone this treatment before?

"Vericiguat is being trialed in 316 cities and 34 countries. The first trial was completed in 2021 by Merck Sharp & Dohme Corp. 6000 patients were involved, the study completed Phase 3 drug approval, and 18294 follow-up trials have been conducted."

Answered by AI

What other data is available about Vericiguat?

"As of now, there is 1 ongoing Vericiguat study in Phase 3 with 460 clinical trial sites worldwide. The most active city for research is Haikou, Hainan; however, Vericiguat trials are conducted in many other places."

Answered by AI

Has Vericiguat received government sanctioning for medical use?

"There is both efficacy and safety data from previous clinical trials to support the use of Vericiguat, so it received a score of 3."

Answered by AI

If a patient wanted to participate in this clinical trial, could they sign up today?

"Yes, as of today, this study is still actively looking for individuals to participate. According to the information available on clinicaltrials.gov, the posting date was November 2nd 2021 and the most recent edit was done on November 3rd 2022. In total, they are hoping to have 6000 people take part in the trial at 95 different locations."

Answered by AI

At how many distinct geographical locations is this research being conducted?

"There are 95 clinical trial sites for this particular study, some of which include Franciscan Physician Network - Indiana Heart Physicians in Indianapolis, Indiana, Accellacare - Wilmington in Wilmington, North carolina, and Diex Recherche Trois-Rivieres in Trois-Rivieres, Quebec."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Valley Clinical Trials, Inc. ( Site 0085)
CHEAR Center LLC ( Site 0009)
Dallas VA Medical Center ( Site 0084)
Recent research and studies
clinicaltrials.govStudy
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
2021. "A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093933.
~1500 spots leftby Mar 2025
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