Systematic Escalation of diuREtics With Natriuresis in Heart Failure Patients: SERENA Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Evidence of significant reduction of congestion defined as absolute reduction of at least 1 point in wet score grading of congestion after 48 hours of treatment
研究概览
简要总结
The present is a multicenter, prospective, randomized, open-label, blinded end-point trial aiming to investigate the clinical benefit of a stepwise, natriuresis-driven diuretic strategy versus standard diuretic treatment in patients with acute decompensated heart failure with reduced ejection fraction (HFrEF) and low early urinary sodium excretion. The study will focus on patients at increased risk of resistance to diuretic therapy. In particular, patients admitted to the emergency department and cardiac intensive care unit due to an on-chronic or de-novo acute decompensated HF episode with a predominantly "wet" profile and low early spot urinary sodium (UNa+) excretion will be considered. Spot natriuresis is a low-cost, non-demanding laboratory test in use to identify diuretic-resistant patients with an inherent poor prognosis. Whether the early identification of diuretic resistant patients and the consequent more aggressive treatment may lead to a better outcome has not been demonstrated by randomized studies. This trial aims to assess if an intensive stepwise diuretic approach guided by systematic urinary output assessment including natriuresis evaluation versus a standard diuretic strategy based on urinary output alone effectively leads to faster euvolemia achievement and better prognosis in a real-world setting.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission for acute decompensate chronic heart failure or acute de novo heart failure
- •Ejection Fraction <40%
- •Severe signs and symptoms of congestion with modified wet score ≥ 12
- •Spot urinary sodium excretion ≤ 70 mEq/L at 2 hours from first intravenous loop diuretic administration
- •Systolic blood pressure ≥90 mmHg
排除标准
- •Reversible etiology of acute heart failure (including acute coronary syndromes, myocarditis, acute pulmonary embolism, acute rhythm disorders, severe organic valve disease)
- •Cardiogenic shock at admission or sign of hypoperfusion needing inotropic agents or mechanical circulatory support.
- •eGFR lower than 15 ml/min/1.73m2 or dialysis
- •Pregnancy or breastfeeding
结局指标
主要结局
Evidence of significant reduction of congestion defined as absolute reduction of at least 1 point in wet score grading of congestion after 48 hours of treatment
时间窗: 48 hours
Assessment of WET score (Gheorghiade et al, EJHF 2010)
次要结局
- Treatment failure, defined as persistent congestion (graded by wet score ≥12/20) after 24, 48 and 72 hours of diuretic treatment or need for renal replacement therapy.(24,48 and 72 hours)
- Freedom from congestion at 48 hours, defined as jugular venous pressure of <8 cm, with no orthopnea and with trace peripheral edema or no edema(48 hours)
- Worsening or persistent heart failure(48 hours)
- Composite endpoint of all-cause mortality, urgent LVAD implant or Heart Transplantation at 30 and 90 days.(30 and 90 days)
- All-cause mortality(30 and 90 days)
- Cardiac cause mortality(30 and 90 days)
- Rehospitalization for heart failure(30 and 90 days)
- Worsening renal function(48 hours)
- Incidence of severe hypokalemia, severe hyponatremia or symptomatic electrolytes disorders during treatment protocol(72 hours)
- Severe symptomatic hypotension(72 hours)
研究者
Simone Frea
MD, Cardiologist
A.O.U. Città della Salute e della Scienza - Molinette Hospital