Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.

NCT07377019 · tracked via the Priya Life Science Denmark tracker

Sponsor

Odense University Hospital

Phase

Not applicable

Started

2026-01

Last updated

2026-01-29

Condition(s) studied

Acute Decompensated Heart Failure (ADHF)

Investigational drug(s) / intervention(s)

Pulsatile Compression Boots (PCB)

Pulsatile Compression Boots (PCB): Each boot has eight chambers that can be inflated to between 30 and 240 mmHg. The first chamber that inflates is at ankle level. When this chamber has achieved the predefined pressure for 17 seconds, the next proximal chamber (chamber two) inflates while the pressure in the distal (ankle) chamber is maintained at constant pressure. This sequence continues until the most proximal chamber at the thigh (chamber eight) has been inflated and has held the maximum pressure for 17 seconds. Thereafter, all the chambers open to release the air, and there is a pause for 30 seconds. The sequence then starts again and continues for 30 minutes. This 30-minute sequence is termed one "session". Pulsatile compression therapy will be applied three sessions per day.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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: 1. Heart failure with reduced ejection fraction (HFrEF): * Signs and/or symptoms of HF * Left ventricular ejection fraction (LVEF) ≤ 40% 2. Heart failure with mildly reduced ejection fraction (HFmrEF): * Signs and/or symptoms of HF * LVEF 41 - 49% 3. 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 Criteria: * 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

Primary outcome measure(s)

Change in systolic pulmonary arterial pressure (sPAP) from baseline to hospital discharge. — 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

Trial sites (1)

Facility	City	Region	Status
Cardiovascular Research Unit. Odense University Hospital, Svendborg.	Svendborg	Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07377019 on ClinicalTrials.gov ↗ ← All trials in Denmark