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.
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)
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)
Parallel
Vericiguat tablet
DrugGroup 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 / Valsartan
DrugGroup A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment
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
Death from cardiovascular event
If patient will die during 3 months follow-up
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
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Khawaja Danish Ali
Lead sponsor
Armed Forces Institute of Cardiology, Pakistan
Sponsor institution
