Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Requirement of hospitalization for heart failure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment
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.
干预措施: Vericiguat tablet (Drug)
Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment
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.
干预措施: Sacubitril / Valsartan (Drug)
Group B patients who will be prescribed standard treatment only (sacubitril-valsartan)
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.
干预措施: Sacubitril / Valsartan (Drug)
结局指标
主要结局
Requirement of hospitalization for heart failure
时间窗: 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
时间窗: 03 months
If patient will die during 3 months follow-up
次要结局
- Side effects(03 months)
研究者
Khawaja Danish Ali
Principal Investigator
Armed Forces Institute of Cardiology, Pakistan