The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.
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.
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.
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:
1. 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:
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.
Inclusion Criteria:
Evidence of heart failure - at least one of the following:
Heart failure with reduced ejection fraction (HFrEF):
Heart failure with mildly reduced ejection fraction (HFmrEF):
Heart failure with preserved ejection fraction (HFpEF):
Evidence of elevated pulmonary artery pressure - at least one of the following:
Additional echocardiographic criteria:
- Left atrial end-systolic volume index > 34 mL/m2
Exclusion Criteria:
freja.sonder.madsen@rsyd.dk+4522111245
Jess.Lambrechtsen@rsyd.dk004563202402
Svendborg, 5700, Denmark
freja.sonder.madsen@rsyd.dk004522111245
Jess.Lambrechtsen@rsyd.dk