PhD-student
Freja Sønder Madsen
Cardiovascular Research Unit, OUH Svendborg
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 01.03.2026 | |
| Slut | 28.02.2029 | |
The efficacy and safety of pulsatile compression boots in patients with acute decompensated heart failure. A randomized, controlled trial (The COMPLEX study)
Short summary
This randomized controlled trial investigates the efficacy, safety, and feasibility of pulsatile compression boots (PCB) as an adjunct to intravenous diuretics in patients hospitalized with acute decompensated heart failure and bilateral leg edema. The study aims to assess hemodynamic and renal effects, hypothesizing that PCB improves decongestion and preserves renal function compared to standard care.
Rationale
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. We know 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. PCB 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. PCB 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 PCB 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: The aim of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and feasibility of using PCB in combination with IV diuretics in patients with mild to moderate HF admitted with worsening symptoms and bilateral LE edema. The study specifically aims to determine whether the combined use of PCB and diuretics can improve hemodynamic and renal function parameters compared to standard care with diuretics alone. The study is designed to: 1. Assess the impact of PCB treatment on systolic pulmonary arterial pressure (sPAP), as a key hemodynamic parameter, hypothesizing that PCB will reduce sPAP in patients by enhancing venous return without exacerbating HF. 2. Evaluate the effect of PCB on estimated glomerular filtration rate (eGFR), as a surrogate measure of renal function, hypothesizing that PCB will contribute to the maintenance or improvement of renal function during decongestion treatment in HF patients.
Description of the cohort
The study consists of patients hospitalized at the Cardiopulmonary Medicine Department at OUH Svendborg, with acute HF and bilateral leg edema, who are initially treated with IV diuretics. These patients will be screened for potential inclusion in the study.
Data and biological material
The study will collect both clinical data and biological material. Biological samples include blood and urine, obtained at baseline, after the fifth PCB session, and at discharge. Blood samples will be analyzed for cardiac (NT-proBNP) and renal biomarkers (creatinine, eGFR, cystatin C). Urine samples will be analyzed for albumin-to-creatinine ratio (UACR). Collected data include demographic and clinical characteristics (age, sex, medical history, medication use), echocardiographic, lung and renal ultrasound parameters, leg circumference, diuretic use, NYHA classification, congestion score, and quality of life (LYMQOL questionnaire).
Collaborating researchers and departments
Department of Medicine, OUH Svendborg