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Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.
Sponsor: Odense University Hospital
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.
Official title: The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-01
Completion Date
2028-04
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Cardiovascular Research Unit. Odense University Hospital, Svendborg.
Svendborg, Denmark