A Phase 4 interventional study of Vericiguat tablet and Placebo in Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by National Institute of Cardiovascular Diseases, Pakistan. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by National Institute of Cardiovascular Diseases, Pakistan · Phase 4, Interventional, and Treatment
To compare the effectiveness and safety of Vericiguat with Standard Medical Treatment in Patients with Heart Failure and Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF) remains a major cause of morbidity, mortality, and healthcare utilization despite advances in guideline-directed medical therapy. Patients who experience worsening heart failure events, including hospitalization or the need for urgent outpatient treatment, remain at increased risk of recurrent cardiovascular events and represent a high-risk population requiring additional therapeutic strategies.
The nitric oxide-soluble guanylate cyclase (NO-sGC)-cyclic guanosine monophosphate (cGMP) pathway plays an important role in maintaining cardiovascular function. In heart failure, endothelial dysfunction and reduced nitric oxide bioavailability may impair this pathway, contributing to vascular dysfunction, myocardial remodeling, and disease progression.
Vericiguat is an oral soluble guanylate cyclase stimulator that enhances cGMP production by directly stimulating soluble guanylate cyclase and increasing its sensitivity to endogenous nitric oxide. This mechanism provides a novel therapeutic approach that differs from conventional heart failure treatments targeting neurohormonal pathways.
Previous clinical evidence, including the VICTORIA trial, demonstrated that vericiguat reduced the risk of cardiovascular death or first hospitalization for heart failure among patients with chronic heart failure and recent worsening heart failure events. However, further evaluation of its effectiveness and safety in specific clinical settings and populations remains important.
This randomized, placebo-controlled, double-blind clinical trial will evaluate the effectiveness and safety of vericiguat in patients with heart failure with reduced ejection fraction receiving standard medical therapy. The study aims to determine whether the addition of vericiguat provides further clinical benefit compared with standard therapy alone in this high-risk patient population.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 500 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →National Institute of Cardiovascular Diseases, Pakistan is the lead sponsor of 23 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vericiguat 10 mg (titrated from 2.5 mg, to 5 mg, and to 10 mg), on a background of standard of care
Drug: Vericiguat tablet
Standard of care medications with placebo.
Drug: Placebo
Vericiguat 10 mg (titrated from 2.5 mg, to 5 mg, and to 10 mg), on a background of standard of care
Also known as: VERIZOT
Participants will receive a matching placebo tablet. The placebo will follow the same dosing schedule as the study drug (2.5 mg, 5 mg, and 10 mg) to maintain blinding.
Also known as: VERIZOT
Quality of life using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated, patient-reported instrument that assesses health status, including symptoms, physical limitations, social limitations, and quality of life in patients with heart failure. The Overall Summary Score ranges from 0 to 100, with higher scores indicating better health status. The primary endpoint is the change in the KCCQ-12 Overall Summary Score from baseline to Month 6.
Time frame: Baseline to Month 6
First Hospitalization for Heart Failure
Time to first hospitalization for worsening heart failure during the study follow-up.
Time frame: From enrollment to Month 6
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vericiguat
National Institute of Cardiovascular Diseases, Pakistan