Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.
Key facts
- Where
- Svendborg, DenmarkSee the site
Where in Denmark
- Cardiovascular Research Unit, Odense University Hospital - SvendborgSvendborg, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT07377019
- Record updated
- 29 January 2026
- Original description
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.Read full original descriptionShow less
The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
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.
Inclusion: 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.
Exclusion: Need for treatment with inotropes or vasopressors; New York Heart Association classification (NYHA) class IV; 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); LVEF < 20%; Pregnancy; Life expectancy less than 1 year for any reason; Expected hospital stay less than 1 day; Diastolic left ventricular diameter > 70 mm; Permanent dialysis; Manifest acute kidney injury with oliguria; Current high-pressure pulmonary edema.