A Randomized Trial Comparing Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Patients Hospitalized for Decompensated Chronic Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- number of patients requiring hospitalization
研究概览
简要总结
The goal of this clinical study is to compare treatment regimens of loop diuretics in patients with decompensated heart failure. The main aim is to answer if early change from intravenous to oral loop diuretics is safe and effective.
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
- •Patient hospitalized due to exacerbation of heart failure symptoms, where AHF is the main cause of hospitalization. To be included in the study, all criteria 1 to 6 must be met:
- •Fluid Retention Features:
- •Described congestion above the lung fields on chest X-ray
- •rales on chest auscultation
- •Peripheral edema, yielding to pressure occurring within the limbs or the sacral part of the spine
- •Increased pressure in the jugular veins (>=8 cm H2O)
- •The concentration of natiuretic peptides must be assessed within 24 hours of admission to the hospital and be:
- •✔ NTpro-BNP >450 pg/mL for <55 years, 900 pg/mL for 55-75 years, and >1800 pg/mL for >75 years
- •Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent)
- •Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry)
- •Age >= 18 years
- •The study participant gave and signed an informed consent to participate in the study. No medical procedure related to the study was performed prior to giving informed consent.
排除标准
- •Shortness of breath caused by respiratory infection, exacerbation of bronchial asthma, COPD
- •Body temperature > 38 C, signs of active infection requiring antibiotic therapy, sepsis, infective endocarditis
- •An episode of acute coronary syndrome, stroke or TIA within 6 months before randomization
- •Severe valvular disease requiring or in the process of qualifying for repair
- •Patients requiring dialysis (in the past, during hospitalization or in the process of qualifying for dialysis)
- •History of alcohol abuse in the last 2 years before randomization
- •Pregnancy or breastfeeding
- •Active cancer or in remission for less than 5 years
研究组 & 干预措施
Group 1
prolonged intravenous loop diuretic treatment - furosemide
干预措施: Furosemide Injection (Drug)
Group 2
Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose
干预措施: Furosemide Pill 150% equivalent iv dose (Drug)
Group 3
Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose
干预措施: Furosemide Pill 200% equivalent iv dose (Drug)
结局指标
主要结局
number of patients requiring hospitalization
时间窗: 12 weeks
any hospitalization due to cardiovascular reasons
Time to hospitalization measured in days
时间窗: Up to 12 weeks
Time to any hospitalization due to cardiovascular reasons
次要结局
- New York Heart Association NYHA class(6 and12 weeks)
- assessment of quality of life(12 weeks)
- Death(12 weeks)
研究者
Zbigniew Siudak
Professor
Jan Kochanowski University