NCT07377019Not yet recruiting
Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.
The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 12 Sept 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Odense University Hospital
- Diseases
- Heart failure
- NCT number
- NCT07377019
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jan 2026 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Need for treatment with inotropes or vasopressors
Other illness
- New York Heart Association classification (NYHA) class IV
- 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)
Lab values
- LVEF \< 20%
Other
- Pregnancy
- Life expectancy less than 1 year for any reason
- Expected hospital stay less than 1 day
- Diastolic left ventricular diameter \> 70 mm
- Permanent dialysis
- Manifest acute kidney injury with oliguria
- Current high-pressure pulmonary edema
Who the study is looking for
- 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
- 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.
- Evidence of elevated pulmonary artery pressure - at least one of the following:
- Systolic pulmonary artery pressure (sPAP) \> 35 mmHg
- Tricuspid regurgitation gradient (TRG) \> 30 mmHg
- Severe tricuspid regurgitation and VCI \> 20 mm.
- Additional echocardiographic criteria:
- \- Left atrial end-systolic volume index \> 34 mL/m2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiovascular Research Unit, Odense University Hospital - Svendborg Coordinator of this site? Confirm its status | Svendborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.