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

NCT07377019 | Not Yet Recruiting

• 1 other identifier: COMPLEX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Decompensated Heart Failure (ADHF)

Keywords

Acute Decompensated Heart Failure; Heart failure; Compression therapy; Cardiorenal syndrome

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (25)

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

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

• Change in NT-proBNP

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

• Change in E/A-ratio

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

• Change in é septal and lateral

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

Other Outcomes (8)

• Change in length of hospital stay

  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 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

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

Study Arms (2)

Pulsatile compression boots (PCB)

EXPERIMENTAL

Receives sessions with PCB (YourBoots, CE approved), as an add on intervention during the entire hospital stay. The PCB intervention will be blinded for the treating clinicians as far as possible in a clinical setting. Furthermore, the study will not interfere with the treating clinician' choice of treatment in general.

Device: Pulsatile Compression Boots (PCB)

Usual care

NO INTERVENTION

Receives either no non-pharmacological treatment or the non-pharmacological treatment chosen by the clinician (e.g. compression bandages), but no compression boots.

Interventions

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.

Also known as: Pneumatic compression boots, Intermittent pneumatic compression boots, Sequential compression boots, Pneumatic compression devices, Dynamic compression boots, Pulsatile compression therapy

Pulsatile compression boots (PCB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving written informed consent
• Bilateral LE edema - defined as: Pitting edema scale \> 1, bilaterally
• Initial IV diuretic treatment
• Evidence of heart failure - at least one of the following:
• Heart failure with reduced ejection fraction (HFrEF):
• Signs and/or symptoms of HF
• Left ventricular ejection fraction (LVEF) ≤ 40%
• Heart failure with mildly reduced ejection fraction (HFmrEF):
• Signs and/or symptoms of HF
• LVEF 41 - 49%
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Cardiovascular Research Unit. Odense University Hospital, Svendborg.

Svendborg, 5700, Denmark

Location

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Freja S. Madsen, M.D., Ph.D student

  Cardiovascular Research Unit, OUH, Svendborg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Freja S. Madsen, M.D., Ph.D student

CONTACT

+4522111245; freja.sonder.madsen@rsyd.dk

Jess Lambrechtsen, Professor

CONTACT

004563202402; Jess.Lambrechtsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: January 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DK (1)