Acute Decompensated Heart Failure (ADHF)COMPLEXNCT07377019
Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.
A study testing Pulsatile Compression Boots (PCB) in people with Acute Decompensated Heart Failure (ADHF), run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Pulsatile Compression Boots (PCB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Cardiovascular Research Unit. Odense University Hospital, Svendborg.
Svendborg, 5700
Freja S. Madsen, M.D., Ph.D. student, 004522111245, freja.sonder.madsen@rsyd.dk
Jess Lambrechtsen, Professor, Jess.Lambrechtsen@rsyd.dk
About this study
Official title: The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled 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.
Read more
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.
Read the detailed description
Background:
Compression therapy is an effective treatment for fluid accumulation in the legs (leg edema). Nevertheless, it is only used sporadically and inconsistently in patients with acute heart failure (HF) and leg edema, even though leg edema is a major problem in these hospitalized patients and compression therapy could help alleviate it.
Acute HF is often complicated by leg edema, which causes pain, reduced mobility, and consequently reduced quality of life. It is well-known that compression therapy can reduce leg edema and is standard treatment for leg edema caused by venous and lymphatic disease, but not for HF. Currently, the standard treatment for HF-related leg edema is diuretic medication. However, this is associated with challenges such as worsening kidney function and prolonged hospitalizations.
No randomized controlled trials have evaluated compression therapy as an adjunct to diuretics in HF, and neither Danish nor European HF guidelines mention its use. This represents an important knowledge gap.
Pulsatile compression therapy are a relatively new modality that mimic the natural muscular venous pump activated during walking. Studies show that compression therapy can increase venous return to the heart. This may potentially improve cardiac function, according to the Frank-Starling mechanism, and enhance renal blood flow, thereby allowing more effective fluid removal.
Pulsatile compression therapy thus represents a non-pharmacological approach with the potential to reduce edema, optimize decongestion, shorten hospitalization, and improve quality of life in this large patient population.
This project investigates the clinical efficacy and safety of pulsatile compression therapy in patients hospitalized with acute HF and leg edema through a randomized controlled trial, which will provide important clinical knowledge on compression therapy for HF patients
Aim:
This randomized, controlled clinical trial will evaluate the efficacy, safety, and feasibility of using pulsatile compression therapy in combination with IV diuretics in patients with mild to moderate HF admitted with worsening symptoms and bilateral leg edema. The study is designed to:
- Assess the impact of pulsatile compression therapy on systolic pulmonary arterial pressure (sPAP), as a key hemodynamic parameter.
Hypothesis:
The investigators hypothesize that treatment with a combination of pulsatile compression therapy and diuretics is a safe and feasible approach. The investigators hypothesize that this combined therapy will safely improve hemodynamic parameters, through the activation of the Frank-Starling mechanism, and subsequently improve renal perfusion, compared with standard diuretic therapy alone. This may optimize diuretic response and reduce the risk of developing cardiorenal syndrome.
Methods:
The COMPLEX study is a prospective, randomized, controlled trial conducted at the Cardiovascular Research Unit in Svendborg Hospital, Denmark. The study population consist of patients hospitalized with acute decompensated HF and bilateral leg edema, who are initiated with intravenous diuretics. Onehundred-and-ten participants are anticipated to take part in the study including a pilot study of 10 participants. Participants are randomized in a 1:1 ratio to receive either treatment with pulsatile compression therapy during hospitalisation, or standard treatment without pulsatile compression therapy. All participants will undergo the following examinations at baseline:
- Ultrasound examination of the heart (echocardiography), the kidneys and the lungs
- Physical examination, including measurement of leg circumference
- Blood- and urine samples
- Registration of "Congestions Score" and "NYHA classification".
- Patient-reported quality of life will be measured using the validated LYMQOL Leg questionnaire.
These examinations will be repeated after the 5th treatment with pulsatile compression therapy (the control group will undergo assessments at a corresponding time point) and at discharge.
Ninety days after discharge, the investigators will review medical records to assess whether participants have experienced a heart failure-related readmission.
Sample size estimation:
A reduction in the primary endpoint of 15% is anticipated in participants assessed in the COMPLEX study compared to usual care. With a power of 0,80 and a two-sided alpha value of 0,05, 90 participants are needed. Accounting for a 10% dropout rate, approximately 100 participants will need to be included in the study.
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Being tested
- Pulsatile Compression Boots (PCB)
- Keywords
- Acute Decompensated Heart Failure, Heart failure, Compression therapy, Cardiorenal syndrome
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile Compression Boots (PCB)Device
Also called Pneumatic compression boots, Intermittent pneumatic compression boots, Sequential compression boots, Pneumatic compression devices
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 by transthoracic echocardiography Unit: cm/s
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left ventricular ejection fraction (LVEF)
Measured by transthoracic echocardiography using Simpson's biplane method. Unit: %
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in Global Longitudinal Strain (GLS)
Measured by transthoracic echocardiography. Unit: %
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left ventricular stroke index
Measured by transthoracic echocardiography Unit: ml/m^2
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in cardiac ouput
Measured by transthoracic echocardiography. Unit: l/min
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in cardiac index
Measured by transthoracic echocardiography. Unit: l/min/m^2
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left atrial end-systolic volume
Measured by transthoracic echocardiography using the apical four-chamber view at end-ventricular systole.
Unit: ml
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left atrial end-systolic volume index
Measured by transthoracic echocardiography using the apical four-chamber view at end-ventricular systole.
Unit: ml/m^2
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left atrial strain
Measured by transthoracic echocardiography. Unit: %
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Measured by echocardiography, using M-mode. Unit: mm.
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular s'
Measured by transthoracic echocardiography. Unit: m/s
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular strain
Measured by transthoracic echocardiography. Unit: %
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular end-systolic volume index
Measured by transthoracic 3D echocardiography . Unit: ml/m^2
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in Right Ventricular end-diastolic volume index
Measured by transthoracic 3D echocardiography Unit: ml/m^2
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular stroke volume index
Measured by transthoracic 3D echocardiography Unit: ml/m^2
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in the diameter of Vena Cava Inferior
Measured by transthoracic echocardiography. Unit: mm.
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in renal artery peak systolic velocity
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: cm/s
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in renal artery end-diastolic velocity
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: cm/s
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in renal artery resistive index
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: Dimensionless
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in the time-averaged mean and maximum velocities in the renal artery.
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: cm/s
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in urine albumin-to-creatinine ratio (UACR)
Measured by urine sample. Unit: mg/g
Measured: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Freja Sønder Madsen, Odense University Hospital
- Investigators
- Freja S. Madsen, M.D., Ph.D student, Principal investigator, Cardiovascular Research Unit, OUH, Svendborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377019
- Sponsor's protocol ID
- COMPLEX
- Acronym
- COMPLEX
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT07377019
- Acronym / sponsor ID
- COMPLEX / COMPLEX
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Keywords
- Acute Decompensated Heart Failure, Heart failure, Compression therapy, Cardiorenal syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Compression therapy is an effective treatment for fluid accumulation in the legs (leg edema). Nevertheless, it is only used sporadically and inconsistently in patients with acute heart failure (HF) and leg edema, even though leg edema is a major problem in these hospitalized patients and compression therapy could help alleviate it.
Acute HF is often complicated by leg edema, which causes pain, reduced mobility, and consequently reduced quality of life. It is well-known that compression therapy can reduce leg edema and is standard treatment for leg edema caused by venous and lymphatic disease, but not for HF. Currently, the standard treatment for HF-related leg edema is diuretic medication. However, this is associated with challenges such as worsening kidney function and prolonged hospitalizations.
No randomized controlled trials have evaluated compression therapy as an adjunct to diuretics in HF, and neither Danish nor European HF guidelines mention its use. This represents an important knowledge gap.
Pulsatile compression therapy are a relatively new modality that mimic the natural muscular venous pump activated during walking. Studies show that compression therapy can increase venous return to the heart. This may potentially improve cardiac function, according to the Frank-Starling mechanism, and enhance renal blood flow, thereby allowing more effective fluid removal.
Pulsatile compression therapy thus represents a non-pharmacological approach with the potential to reduce edema, optimize decongestion, shorten hospitalization, and improve quality of life in this large patient population.
This project investigates the clinical efficacy and safety of pulsatile compression therapy in patients hospitalized with acute HF and leg edema through a randomized controlled trial, which will provide important clinical knowledge on compression therapy for HF patients
Aim:
This randomized, controlled clinical trial will evaluate the efficacy, safety, and feasibility of using pulsatile compression therapy in combination with IV diuretics in patients with mild to moderate HF admitted with worsening symptoms and bilateral leg edema. The study is designed to:
- Assess the impact of pulsatile compression therapy on systolic pulmonary arterial pressure (sPAP), as a key hemodynamic parameter.
Hypothesis:
The investigators hypothesize that treatment with a combination of pulsatile compression therapy and diuretics is a safe and feasible approach. The investigators hypothesize that this combined therapy will safely improve hemodynamic parameters, through the activation of the Frank-Starling mechanism, and subsequently improve renal perfusion, compared with standard diuretic therapy alone. This may optimize diuretic response and reduce the risk of developing cardiorenal syndrome.
Methods:
The COMPLEX study is a prospective, randomized, controlled trial conducted at the Cardiovascular Research Unit in Svendborg Hospital, Denmark. The study population consist of patients hospitalized with acute decompensated HF and bilateral leg edema, who are initiated with intravenous diuretics. Onehundred-and-ten participants are anticipated to take part in the study including a pilot study of 10 participants. Participants are randomized in a 1:1 ratio to receive either treatment with pulsatile compression therapy during hospitalisation, or standard treatment without pulsatile compression therapy. All participants will undergo the following examinations at baseline:
- Ultrasound examination of the heart (echocardiography), the kidneys and the lungs
- Physical examination, including measurement of leg circumference
- Blood- and urine samples
- Registration of "Congestions Score" and "NYHA classification".
- Patient-reported quality of life will be measured using the validated LYMQOL Leg questionnaire.
These examinations will be repeated after the 5th treatment with pulsatile compression therapy (the control group will undergo assessments at a corresponding time point) and at discharge.
Ninety days after discharge, the investigators will review medical records to assess whether participants have experienced a heart failure-related readmission.
Sample size estimation:
A reduction in the primary endpoint of 15% is anticipated in participants assessed in the COMPLEX study compared to usual care. With a power of 0,80 and a two-sided alpha value of 0,05, 90 participants are needed. Accounting for a 10% dropout rate, approximately 100 participants will need to be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsatile compression boots (PCB) | Experimental | Device: Pulsatile Compression Boots (PCB)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Capable of giving written informed consent
- Bilateral LE edema - defined as: Pitting edema scale > 1, bilaterally
- Initial IV diuretic treatment
- Heart failure with reduced ejection fraction (HFrEF):
- Heart failure with mildly reduced ejection fraction (HFmrEF):
Key exclusion criteria (13 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsatile Compression Boots (PCB)Also: Pneumatic compression boots, Intermittent pneumatic compression boots, Sequential compression boots, Pneumatic compression devicesEach 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. | Device | Pulsatile compression boots (PCB) |
Primary outcome
Change in systolic pulmonary arterial pressure (sPAP) from baseline to hospital discharge.
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. sPAP will be used as a surrogate marker of the degree of cardiac backward failure. Unit: mmHg
25 secondary outcomes
Change in estimated glomerular filtration rate (eGFR) from baseline to hospital discharge.
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in NT-proBNP
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
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)
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in é septal and lateral
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left ventricular ejection fraction (LVEF)
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in Global Longitudinal Strain (GLS)
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left ventricular stroke index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in cardiac ouput
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in cardiac index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left atrial end-systolic volume
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left atrial end-systolic volume index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in left atrial strain
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular s'
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular strain
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular end-systolic volume index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in Right Ventricular end-diastolic volume index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in right ventricular stroke volume index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in the diameter of Vena Cava Inferior
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in renal artery peak systolic velocity
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in renal artery end-diastolic velocity
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in renal artery resistive index
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in the time-averaged mean and maximum velocities in the renal artery.
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Change in urine albumin-to-creatinine ratio (UACR)
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Freja S. Madsen, M.D., Ph.D student principal investigator
Cardiovascular Research Unit, OUH, Svendborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsatile Compression Boots (PCB) in people with Acute Decompensated Heart Failure (ADHF), run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Freja S. Madsen, M.D., Ph.D student (+4522111245, freja.sonder.madsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic pulmonary arterial pressure (sPAP) from baseline to hospital discharge. (time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.