Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial

This study will compare the outcomes of Vericuguat and placebo in patient with decompensated heart failure . This study will carry out after approval from IERB. Seventy patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history including name, age, gender, duration of heart failure, history of alcoholism, smoking, diabetes, hypertension, EF at baseline and NYHA class will be noted. Patients will be randomly divided in two groups by using lottery method. Outcomes will be assessed at in terms of hospitalization for heart failure, death from cardiovascular event and side effects.

Study Overview

• Status: Recruiting
• Conditions: Decompensated Heart Failure
• Intervention / Treatment: Drug: Vericiguat tablet; Drug: Sacubitril / Valsartan

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr Khawaja Danish Ali, MBBS; Phone Number: +923448890893; Email: khawajadanishali@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • Recruiting
      • Armed Forces Institute of Cardiology. Pakistan
      • Contact: Prof Dr Muhammad Nadir Khan, MBBS, FCPS; Phone Number: +923219156153; Email: yesnadirkhan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with decompensated heart failure (patients with left ventricular ejection fraction ≤45% presenting with NYHA functional class III-IV symptoms or worsening class II symptoms. Along with elevated natriuretic peptide levels defined as NT-proBNP >1000 pg/mL in patients with sinus rhythm and >1600 pg/mL in patients with atrial fibrillation in the absence of alternative causes of biomarker elevation)

Exclusion Criteria:

• Patients with blood pressure <100 mmHg;
• concurrent or anticipated use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors
• use of intravenous inotropes or implantable left ventricular assist devices (on medical record)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment; Sixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history will be noted. patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan).All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa.	Drug: Vericiguat tablet; Group A, patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan); Drug: Sacubitril / Valsartan; Group A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment
Active Comparator: Group B patients who will be prescribed standard treatment only (sacubitril-valsartan); Sixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department randomly. Informed consent will be taken from attendants. A detailed history will be noted. Patients will be prescribed standard treatment only (sacubitril-valsartan). All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa.	Drug: Sacubitril / Valsartan; Group A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Requirement of hospitalization for heart failure	If Ejection Fraction further reduced and patient need to admit in the hospital for symptoms including pedal edema, pleural effusion, and need intravenous diuretic therapy	03 months
Death from cardiovascular event	If patient will die during 3 months follow-up	03 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	If patient will complaint of mild to moderate gastrointestinal disturbances, Hypotension (BP≥100/60 mmHg) or any other adverse event during 3 months follow-up	03 months

Collaborators and Investigators

• Sponsor: Khawaja Danish Ali

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Heart failure; Emergency Department; Vericuguat
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Pathological Conditions, Signs and Symptoms; Heart Failure; Emergencies; sacubitril and valsartan sodium hydrate drug combination; vericiguat
• Other Study ID Numbers: 25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No