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

Phase 1RecruitingNCT07444398

Khawaja Danish Ali130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Decompensated Heart Failure

Interventions

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)

Sacubitril / ValsartanDRUG

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Armed Forces Institute of Cardiology. Pakistan

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 03 months

Death from cardiovascular event

If patient will die during 3 months follow-up

Time frame: 03 months

Secondary Outcomes

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

Time frame: 03 months

Central Contacts

Dr Khawaja Danish Ali, MBBS

CONTACT

+923448890893 khawajadanishali@gmail.com

Data from ClinicalTrials.gov

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