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

ConditionAcute Decompensated Heart Failure (ADHF)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Pulsatile Compression Boots (PCB)
Device
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Pulsatile compression boots (PCB)Experimental treatment 1 intervention

Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Measured by transthoracic echocardiography. sPAP will be used as a surrogate marker of the degree of cardiac backward failure. Unit: mmHg

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Secondary outcomes

Change in estimated glomerular filtration rate (eGFR) from baseline to hospital discharge.

Measured by a blood sample. Renal function will be assessed by eGFR, calculated from serum cystatin C, serving as a surrogate marker of renal function Unit: mL/min/1,73m\^2

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Change in NT-proBNP

Collected by a blood sample. Unit: ng/L

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Change in E/A-ratio

Measured by transthoracic echocardiography. Unit: dimensionless

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Change in E/é (septal and lateral)

Measured by transthoracic echocardiography Unit: dimensionless

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Other outcomes

Change in length of hospital stay

Measured in hours

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Change in pulmonary congestion, assessed by semi-quantitative B-line scoring

Measured by focused lung ultrasound examination using a 14-zone protocol. Quantification of B-lines will be performed as a semi-quantitative assessment of pulmonary congestion. B-lines represent increased extravascular lung fluid and are used as a marker of pulmonary congestion.

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Change in 30- and 90-day readmission rates

Readmissions should be related to heart failure

Time frame

From baseline (Day 1, hospital admission) to 30 and 90 days after discharge

Change in Quality of Life, using LYMQOL-leg questionnaire

LYMQOL-leg is a questionnaire designed to measure quality of life in patients with chronic bilateral leg edema or lymphedema.

Time frame

Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: