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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pulsatile Compression Boots (PCB)

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators