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

NCT07444398 | Recruiting Phase 1

• 1 other identifier: 25
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Decompensated Heart Failure

Keywords

Vericuguat; Heart failure; Emergency Department

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Side effects

  03 months

Study Arms (2)

Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment

EXPERIMENTAL

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; Drug: Sacubitril / Valsartan

Group B patients who will be prescribed standard treatment only (sacubitril-valsartan)

ACTIVE COMPARATOR

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

Interventions

Vericiguat tablet DRUG

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)

Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment

Sacubitril / Valsartan DRUG

Group A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment

Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment; Group B patients who will be prescribed standard treatment only (sacubitril-valsartan)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Khawaja Danish Ali: lead

Study Sites (1)

Armed Forces Institute of Cardiology. Pakistan

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Heart Failure; Emergencies

Interventions

vericiguat; sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Khawaja Danish Ali, MBBS

CONTACT

+923448890893; khawajadanishali@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 2, 2026
• Study Start: January 1, 2026
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)