Decompensated Heart Failure
Conditions
Keywords
Vericuguat, Heart failure, Emergency Department
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.
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)
Group A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment
Sponsors
Khawaja Danish Ali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of hospitalization for heart failure | 03 months | 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 | 03 months | If patient will die during 3 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | 03 months | 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 |
Countries
Pakistan
Contacts
CONTACTDr Khawaja Danish Ali, MBBS
Outcome results
None listed