Lower limb compression therapy for tissue decongestion in acute heart failure: design of a multicentre randomised clinical trial
E Chover-Sierra, J Perez Silvestre, D Garcia Escriva, J Nunez Villota, R De La Espriella Juan, J Civera Gomez, P Llacer Iborra, E Perez Pison, M Pumares Alvarez, M Cobo Marcos, J C Lopez Azor, A Martinez Lopez, F J Pastor Perez, C Simon-Ramon, A Villalobos AbelloAbstract
Introduction
Extravascular tissue congestion is a central pathophysiological component of acute heart failure (HF) and a significant determinant of symptoms and hospitalisation. In patients without overt intravascular congestion, residual interstitial fluid overload is frequently associated with poor response to diuretic therapy and early diuretic resistance. In this clinical phenotype, mobilisation of interstitial fluid into the vascular compartment represents a key therapeutic target. However, evidence supporting non-pharmacological strategies specifically addressing tissue congestion remains scarce.
Objective
To describe the design and rationale of a randomised clinical trial evaluating the efficacy and safety of lower limb compression therapy as an adjunct to diuretic treatment in patients with acute HF and predominant tissue congestion.
Methods
This study is a randomised, multicentre, double-blind, sham-controlled clinical trial. Adult patients with acute decompensated HF within the first 96 hours are eligible if they present bilateral lower limb oedema (≥ grade II/IV), NT-proBNP >1000 pg/mL, and absence of intravascular congestion defined by an inferior vena cava (IVC) diameter ≤21 mm on ultrasound. Participants are randomised 1:1 to active multicomponent lower limb compression therapy (~20 mmHg) or sham compression for 24–72 hours, in addition to standard intravenous loop diuretics. Assessments are performed at randomisation, at 3, 24, 48, and 72 hours, and at follow-up visits at 15 and 30 days. Body weight, lower limb diameters, clinical congestion assessment (edema, pleural effusion, and ascites), and urinary sodium are recorded at all visits (24-hour urine collection at 24 hours). Serial ultrasound evaluation of IVC diameter and collapsibility is performed to assess dynamic changes in congestion. Congestion biomarkers (NT-proBNP and CA125) are measured at randomisation, at 72 hours, and at 15 days. The primary endpoint is the combined change in body weight and cumulative natriuresis at 24 hours. The planned sample size is 106 patients.
Conclusions
This trial will provide robust evidence on a multidisciplinary, non-pharmacological strategy specifically targeting tissue congestion in acute HF. By focusing on a well-defined congestion phenotype, the study may help optimise decongestive management in patients with high diuretic resistance and inform future outcome-driven trials.For image description, please refer to the figure legend and surrounding text.