Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 16
- 主要终点
- Natriuresis
研究概览
简要总结
Randomized 1:1 multicenter double-blind clinical investigation evaluating the efficacy and safety of compression therapy of the lower limbs plus parenteral administration of diuretics vs. administration of parenteral diuretics alone (standard treatment) in patients with decompensated HF and predominantly systemic tissue congestion and absence of intravascular systemic congestion.
Patients will be assigned to standard treatment (parenteral administration of furosemide) plus a non-compressive sham bandage, versus parenteral administration of furosemide plus lower-limb compression therapy. The active compression bandage will be maintained for at least 24 hours and up to a maximum of 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional.
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
- Double (Participant, Investigator)
盲法说明
Participants and blinded investigators will be unaware of treatment allocation. In the control arm, a non-compressive sham bandage will be applied to the lower limbs. The active and sham bandages are designed so that there are no differences on visual inspection by the blinded investigators.
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
- •Patients aged 18 years or older.
- •Patient with clinical judgment of acute decompensated heart failure in the first 96 hours from the start of parenteral diuretic treatment.
- •Patient treated with furosemide at least 40 mg in the last 24 hours.
- •NT-proBNP levels>1000 pg/ml at least 1 time since the onset of decompensation.
- •Presence of tibio-malleolar edema at least grade II/IV at the time of inclusion.
- •Inferior vena cava (IVC) diameter on ultrasonography ≤21 mm at the time of the "screening" visit.
排除标准
- •Being admitted to the Intensive Care Unit.
- •Renal transplant, chronic renal failure stage 5 (eGFR <15 ml/min/1.73m2) or being included in dialysis program (peritoneal/hemodialysis) or in need of ultrafiltration.
- •Absence of peripheral pulses.
- •Ankle brachial index (ABI) <0.
- •History of severe peripheral artery disease.
- •Previous intolerance to compressive bandaging.
- •HF secondary to acute myocardial infarction.
研究组 & 干预措施
Control: Standard treatment + sham bandage
Parenteral administration of furosemide plus a non-compressive sham bandage applied to the lower limbs. The sham bandage consists of a Vendari SOFTPAD® padding bandage and a Vendari DARIFLEX® tubular bandage and is changed every 24 hours.
干预措施: Controll (Other)
Compressive
Compressive therapy of the lower limbs plus parenteral administration of diuretics
干预措施: UrgoK2 / UrgoK2 Lite (Device)
结局指标
主要结局
Natriuresis
时间窗: 24 hours
Changes in natriuresis at 24 hours after randomization.
Weight
时间窗: 24 hours
Changes in weight at 24 hours after randomization
Natriuresis
时间窗: 24 hours after randomization
Natriuresis measured from a 24-hour urine collection starting at randomization.
次要结局
- Inferior vena cava diameter(72 hours)
- CA125(15±3 days)
- Diameter of the lower limbs(72 hours)
- Congestion score(72 hours)
- NT-proBNP(72 hours)
- Doses of furosemide(72 hours)
- Time to oral administration.(72 hours)
- Diameter of the lower limbs(24 and 72 hours after randomization)
- Congestion score(24 and 72 hours after randomization)
- Inferior vena cava diameter(3, 24 and 72 hours after randomization)