Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vericiguat tablet, Sacubitril / Valsartan.
- Who it may be relevant to
- Registry conditions: Decompensated Heart Failure. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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
Primary outcome measures
- Requirement of hospitalization for heart failure [Time frame: 03 months]
- Death from cardiovascular event [Time frame: 03 months]
Secondary outcome measures (1)
- Side effects [Time frame: 03 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Armed Forces Institute of Cardiology. Pakistan — Rawalpindi
Identifiers
NCT: NCT07444398 · 25