NCT Number: NCT07377019
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Svendborg, 5700, Denmark
Casper Falster, M.D., Ph.D.
SUB_INVESTIGATOR
Freja S. Madsen, M.D., Ph.D. student
CONTACT
Freja Sønder Madsen, M.D., Ph.D student
PRINCIPAL_INVESTIGATOR
Jacob Eifer Møller, Professor
SUB_INVESTIGATOR
Jess Lambrechtsen, Professor
CONTACT
Jess Lambrechtsen, Professor
SUB_INVESTIGATOR
Søren Auscher, Post.Doc
SUB_INVESTIGATOR
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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Evidence of heart failure - at least one of the following:
Evidence of elevated pulmonary artery pressure - at least one of the following:
Additional echocardiographic criteria:
Exclusion criteria
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.
Other names: Pneumatic compression boots, Intermittent pneumatic compression boots, Sequential compression boots, Pneumatic compression devices, Dynamic compression boots, Pulsatile compression therapy
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
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
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)
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)
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)
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)
Measured by transthoracic echocardiography Unit: cm/s
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography using Simpson's biplane method. Unit: %
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: %
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography Unit: ml/m^2
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: l/min
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: l/min/m^2
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography using the apical four-chamber view at end-ventricular systole.
Unit: ml
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography using the apical four-chamber view at end-ventricular systole.
Unit: ml/m^2
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: %
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by echocardiography, using M-mode. Unit: mm.
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: m/s
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: %
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic 3D echocardiography . Unit: ml/m^2
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic 3D echocardiography Unit: ml/m^2
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic 3D echocardiography Unit: ml/m^2
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by transthoracic echocardiography. Unit: mm.
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: cm/s
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: cm/s
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: Dimensionless
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by ultrasound of the distal segment of the renal artery using pulsed-wave Doppler.
Unit: cm/s
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured by urine sample. Unit: mg/g
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured in hours
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
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: From baseline (Day 1, hospital admission) to 30 and 90 days after discharge
Readmissions should be related to heart failure
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
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)
Unit: mg.
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Unit: administration per day
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
The total number of calendar days during which the patient receives at least one dose of intravenous loop diuretics during the index hospital admission will be recorded. The outcome is defined as the difference in number of days with intravenous diuretic treatment between treatment groups.
Unit: days
Time frame: Measured at baseline (Day 1, hospital admission) and at hospital discharge (assessed up to 14 days after admission)
Measured in millimeter (mm.) at the ankle, calf and thigh.
Contact information is provided by the study sponsor or research team.
Freja S. Madsen, M.D., Ph.D student
CONTACT
Jess Lambrechtsen, Professor
CONTACT
Odense University Hospital
Other
The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
Acronym: COMPLEX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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