The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in systolic pulmonary arterial pressure (sPAP) from baseline to hospital discharge.
研究概览
简要总结
The aim of this clinical trial is to investigate whether pulsatile compression therapy can support heart and kidney function in patients admitted with acute heart failure and fluid accumulation in the legs.
Pulsatile compression boots, which provide pulsatile compression therapy, work by adding a predefined pressure to the legs in a rhythm that enhances mobilization of peripheral edema and improves venous and lymphatic drainage from the lower extremities. This increased venous return (preload) may allow the heart to fill more effectively and pump more strongly, thereby improving circulation. Better circulation can enhance kidney blood flow, help diuretics work more efficiently, and reduce the risk of complications due to worsening heart failure, affecting both the heart and kidneys.
The investigators want to explore whether adding this therapy to standard diuretic treatment is safe, feasible, and offers benefits compared with standard diuretic treatment alone.
Participants will receive three daily sessions of pulsatile compression therapy alongside usual clinical care.
详细描述
Background:
Compression therapy is an effective treatment for fluid accumulation in the legs (leg edema). Nevertheless, it is only used sporadically and inconsistently in patients with acute heart failure (HF) and leg edema, even though leg edema is a major problem in these hospitalized patients and compression therapy could help alleviate it.
Acute HF is often complicated by leg edema, which causes pain, reduced mobility, and consequently reduced quality of life. It is well-known that compression therapy can reduce leg edema and is standard treatment for leg edema caused by venous and lymphatic disease, but not for HF. Currently, the standard treatment for HF-related leg edema is diuretic medication. However, this is associated with challenges such as worsening kidney function and prolonged hospitalizations.
No randomized controlled trials have evaluated compression therapy as an adjunct to diuretics in HF, and neither Danish nor European HF guidelines mention its use. This represents an important knowledge gap.
Pulsatile compression therapy are a relatively new modality that mimic the natural muscular venous pump activated during walking. Studies show that compression therapy can increase venous return to the heart. This may potentially improve cardiac function, according to the Frank-Starling mechanism, and enhance renal blood flow, thereby allowing more effective fluid removal.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving written informed consent
- •Inclusion within 24 hours from admission
- •Bilateral LE edema - defined as: Pitting edema scale > 1, bilaterally
- •Initial IV diuretic treatment
- •Evidence of heart failure - at least one of the following:
- •Heart failure with reduced ejection fraction (HFrEF):
- •Signs and/or symptoms of HF
- •Left ventricular ejection fraction (LVEF) ≤ 40%
- •Heart failure with mildly reduced ejection fraction (HFmrEF):
- •Signs and/or symptoms of HF
- •LVEF 41 - 49%
- •Heart failure with preserved ejection fraction (HFpEF):
- •Signs and/or symptoms of HF
- •LVEF ≥ 50 %
- •Evidence of structural heart disease (Left atrial enlargement or left ventricular hypertrophy)
- •NT-proBNP > 300pg/mL for patients without ongoing atrial fibrillation/flutter, and NT-proBNP > 600 pg/mL for patients with ongoing atrial fibrillation/flutter.
- •Evidence of elevated pulmonary artery pressure - at least one of the following:
- •Systolic pulmonary artery pressure (sPAP) > 35 mmHg
- •Tricuspid regurgitation gradient (TRG) > 30 mmHg
- •Severe tricuspid regurgitation and VCI > 20 mm.
- •Additional echocardiographic criteria:
- •- Left atrial end-systolic volume index > 34 mL/m2
排除标准
- •Pregnancy
- •Life expectancy less than 1 year for any reason
- •Expected hospital stay less than 1 day
- •New York Heart Association classification (NYHA) class IV
- •LVEF < 20%
- •Diastolic left ventricular diameter > 70 mm
- •Known history or symptoms of peripheral arterial disease (Intermittent claudication or brachial-ankle index with value < 0,9)
- •Significant leg wounds or infections
- •Deep venous thrombosis (DVT)
- •Need for treatment with inotropes or vasopressors
- •Permanent dialysis
- •Manifest acute kidney injury with oliguria
- •Current high-pressure pulmonary edema
研究组 & 干预措施
Pulsatile compression boots (PCB)
Receives sessions with PCB (YourBoots, CE approved), as an add on intervention during the entire hospital stay. The PCB intervention will be blinded for the treating clinicians as far as possible in a clinical setting. Furthermore, the study will not interfere with the treating clinician' choice of treatment in general.
干预措施: Pulsatile Compression Boots (PCB) (Device)
Usual care
Receives either no non-pharmacological treatment or the non-pharmacological treatment chosen by the clinician (e.g. compression bandages), but no compression boots.
结局指标
主要结局
Change in systolic pulmonary arterial pressure (sPAP) from baseline to hospital discharge.
时间窗: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. sPAP will be used as a surrogate marker of the degree of cardiac backward failure. Unit: mmHg
次要结局
- Change in estimated glomerular filtration rate (eGFR) from baseline to hospital discharge.(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in NT-proBNP(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in E/A-ratio(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in E/é (septal and lateral)(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in é septal and lateral(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in left ventricular ejection fraction (LVEF)(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in Global Longitudinal Strain (GLS)(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in left ventricular stroke index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in cardiac ouput(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in cardiac index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in left atrial end-systolic volume(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in left atrial end-systolic volume index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in left atrial strain(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in right ventricular s'(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in right ventricular strain(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in right ventricular end-systolic volume index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in Right Ventricular end-diastolic volume index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in right ventricular stroke volume index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in the diameter of Vena Cava Inferior(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in renal artery peak systolic velocity(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in renal artery end-diastolic velocity(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in renal artery resistive index(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in the time-averaged mean and maximum velocities in the renal artery.(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
- Change in urine albumin-to-creatinine ratio (UACR)(Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission))
研究者
Freja Sønder Madsen
Principal investigator, MD
Odense University Hospital