Clinical Trial

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

Study acronym: COMPLEX
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07377019
Lead Sponsor Odense University Hospital
Conditions Acute Decompensated Heart Failure (ADHF)
Enrollment 100 participants
Start Date 2026-01
Primary Completion 2028-01 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-01-29