Safety and Tolerability of Diuretics Withdrawal in Heart Failure with Reduced Ejection Fraction. REDICAE Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change From Baseline in Dyspnea assessed by a visual analogue scale (VAS)
研究概览
简要总结
REDICAE trial was designed to evaluate the safety and tolerability of diuretics withdrawal in stable, euvolemic chronic outpatients with heart failure with reduced ejection fraction. It is a single-center, randomized, open-label, phase II clinical trial.
详细描述
Treatment of heart failure with reduced ejection fraction (HFrEF) has improved patient survival in recent decades. Diuretics are essentials in acute decompensated heart failure, specially furosemide. However, when patients are stable and euvolemic diuretics (loop diuretics, thiazide diuretics or acetazolamide) might increase adverse effects: renin-angiotensin-aldosterone system activation, renal function impairment or electrolyte disturbances.
The 2021 European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure recommend angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor-neprilysin inhibitor (ARNI), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA) and sodium-glucose co-transporter 2 inhibitors (iSTLT2) as first-line therapy for HFrEF. A significant proportion of patients take a maintenance diuretics dose despite the clinical benefits and prognosis are controversial.
Current clinical guidelines suggest that diuretic use can be reduced or discontinued in selected euvolemic or hypovolemic patients. This statement is based on the results of the ReBIC-1 trial published in 2019, which showed a neutral effect of furosemide discontinuation in stable chronic outpatients with HFrEF treated according to the 2016 ESC heart failure guidelines standards of care.
REDICAE trial was designed to evaluate the safety and tolerability of diuretics withdrawal, not just furosemide, in stable euvolemic chronic outpatients with HFrEF. It is a single-center, randomized, open-label phase II clinical trial.
The pathophysiology of congestion in heart failure is complex and multifactorial. In the REDICAE trial, volume status will be determined by biomarkers, echocardiography and bioelectrical impedance analysis. The patients enrolled in the study will be under contemporary guideline-directed medical therapy, including SGLT2 inhibitors. This trial is the largest prospective trial evaluating the clinical effects of diuretic discontinuation in HFrEF patients under contemporary pharmacological therapy for heart failure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Diuretics withdrawal
干预措施: Diuretics withdrawal (Drug)
Diuretics maintenance
干预措施: Diuretics maintenance (Drug)
结局指标
主要结局
Change From Baseline in Dyspnea assessed by a visual analogue scale (VAS)
时间窗: baseline - 30 days - 90 days - 180 days
VAS scores are scaled from 0 to 100 millimeters (mm). Higher scores mean a worse outcome.
次要结局
- Body Composition Monitor (BCM) of Fresenius Medical Care(baseline - 30 days - 90 days - 180 days)
- Quality of life status(baseline - 30 days - 90 days - 180 days)
- 6 minute walk test(baseline - 30 days - 90 days - 180 days)
- Hepatic vein Doppler(baseline - 30 days - 90 days - 180 days)
- Intra-renal venous Doppler(baseline - 30 days - 90 days - 180 days)
- Tissue fluid overload(baseline - 30 days - 90 days - 180 days)
- Portal vein Doppler(baseline - 30 days - 90 days - 180 days)
- Congestion assessed by lung ultrasound(baseline - 30 days - 90 days - 180 days)
- Variation of plasmatic levels of natriuretic peptides(baseline - 30 days - 90 days - 180 days)
- Inferior vena cava (IVC) diameter(baseline - 30 days - 90 days - 180 days)
- Acute decompensated heart failure events(180 days)
- Ultrasound congestion parameters by Venous Excess Ultrasound (VExUS) protocol(baseline - 30 days - 90 days - 180 days)