Vericiguat for Heart failure

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Heart failure+1 More
Vericiguat - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Heart failure

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to approximately 40 months

Month 40
Time to All-Cause Mortality
Month 40
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Month 40
Time to First Occurrence of CV Death
Month 40
Time to First Occurrence of HF Hospitalization
Month 40
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
Month 40
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)
Time to Total HF Hospitalizations (Including First and Recurrent Events)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Vericiguat
15%Hypotension
7%Anaemia
7%Dizziness
6%Cardiac failure
5%Diarrhoea
5%Nasopharyngitis
5%Dyspnoea
4%Hyperkalaemia
4%Pneumonia
3%Acute kidney injury
2%Chronic kidney disease
2%Syncope
2%Chronic obstructive pulmonary disease
1%Renal failure
1%Sepsis
1%Cardiac failure congestive
1%Urinary tract infection
1%Gastroenteritis
1%Cellulitis
1%Atrial fibrillation
1%Ventricular tachycardia
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02861534) in the Vericiguat ARM group. Side effects include: Hypotension with 15%, Anaemia with 7%, Dizziness with 7%, Cardiac failure with 6%, Diarrhoea with 5%.

Trial Design

2 Treatment Groups

Vericiguat
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

6000 Total Participants · 2 Treatment Groups

Primary Treatment: Vericiguat · Has Placebo Group · Phase 3

Vericiguat
Drug
Experimental Group · 1 Intervention: Vericiguat · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vericiguat
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 40 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,573,204 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,653 Previous Clinical Trials
4,947,607 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,618 Previous Clinical Trials
7,930,825 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with chronic HF on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization were randomized to sacubitril/valsartan or placebo.
A patient has a left ventricular ejection fraction of ≤40% if the percentage of blood that the left ventricle pumps out of the heart in one contraction is less than forty
A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to use contraception during the study intervention period and for at least 1 month after the last dose of study intervention.
Elevated levels of NT-proBNP indicate that the heart is under stress.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Indiana100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%