Diuresis Efficacy in Ambulatory Chronic Heart Failure Patients With Volume Overload- Intra -Patient Comparison of Three Diuretics Regimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Sodium weight
研究概览
简要总结
To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome.
详细描述
The study will assess the efficacy and safety of three (3) different clinically prevailing diuretic regimens. All three regimens are based on furosemide, as mentioned above- a 1st line HF GL2,3 recommended and MOH registered 7 for fluid decongestion, and the two adjuvants medications are also approved as diuretics in HF patients. Better natriuresis will lead to better decongestion in CHF patients with volume overload. It is expected that the better natriuresis will lead to better decongestion, and improvement in favorable markers parameters such as NT pro BNP.
The trial will investigate treatment regimens, readily available, clinically approved ("on-label" in Israel), which can be very easily administered, through an IV infusion or IV and PO administration without additional extra testing or invasive monitoring. The setting is in an established dedicated HF day-care unit at the cardiology department of Rambam Health Campus (RMC)- a tertiary referral academic center.
The knowledge gathered in this study, could be easily adopted by every clinic or hospital in a quick manner with considerable cost-savings with regards to health care expenditure.
Importantly, this study will examine which application of existing decongestive therapies (not novel drugs), based on strong scientific reasoning, will result in a better outcome for patients. Therefore, data from the study will provide information regarding the safety and efficacy of diuretic treatment in the above-mentioned patient population.
The study intends to be a real-life study, in the manner of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Signed written informed consent must be obtained before any study assessment is performed.
- •Male or female patients 18 years of age or older
- •Confirmed Diagnosis of Heart Failure (per ESC guidelines 20212)
- •At least one sign of active congestion at recruitment: Jugular venous pressure(JVP)/Ascites/Edema/Pulmonary rales/Pleural effusion/ Lung ultrasound B lines >3 lines (at 6 sites).
- •Patient is at least on two heart failure drugs including: BB, MRA, sGLT2i, ACEI/ARB/ARNI (or has a clinical reason for its absence) and on oral diuretics for the last 30 days before study inclusion.
排除标准
- •History of myocardial infraction in the last 14 days prior to patient randomization.
- •History of a cardiac transplantation and/or ventricular assist device.
- •Mean blood pressure <60 mmHg at screening
- •Simultaneous use of intravenous inotropes, vasopressors or nitroprusside due to acute decompensated heart failure in the last 14 days.
- •Estimated glomerular filtration rate <20ml/min/1.73m2 at screening
- •Any circumstances where urine collection is not possible.
- •Use of renal replacement therapy or ultrafiltration 30 days prior to patient randomization.
- •Subjects who are pregnant or breastfeeding
研究组 & 干预措施
Diuretic comparison
each participant will be followed for 4 consecutive weeks. during which 3 different diuretic regimens will be given (random sequence). Last week follow up without protocol regimen.
干预措施: IV Furosemide (Drug)
Diuretic comparison
each participant will be followed for 4 consecutive weeks. during which 3 different diuretic regimens will be given (random sequence). Last week follow up without protocol regimen.
干预措施: IV Furosemide and PO Metolazone (Drug)
Diuretic comparison
each participant will be followed for 4 consecutive weeks. during which 3 different diuretic regimens will be given (random sequence). Last week follow up without protocol regimen.
干预措施: IV Furosemide and IV Acetazolamide (Drug)
结局指标
主要结局
Sodium weight
时间窗: 2 weeks after 1st visit
Na Weight (Spot Na \* total volume of urine)
次要结局
- Urine Volume(2 weeks after 1st visit)
- Rate of symptomatic hypotension events(3 weeks after 1st visit)
- rate of worsening renal function events(3 weeks after 1st visit)
- Rate of hyponatremia during treatment phase(3 weeks after 1st visit)
- Rate of dyskalemia events during treatment phase(3 weeks after 1st visit)
- Rate of metabolic acidosis events requiring NaHCO3 supplements(3 weeks after 1st visit)
研究者
Aharon (Ronnie) Abbo MD
Deputy Director, Cardio Vascular Research and Innovation Unit
Rambam Health Care Campus