Lower limb compression in acute heart failure and predominant tissue congestion: rationale and design of the COMPRESSION-HF trial.

aimsAcute decompensated heart failure (ADHF) is often treated with diuretic agents in both the inpatient and ambulatory settings, yet fluid overload frequently persists and is associated with rehospitalization and death. In patients with predominant interstitial fluid expansion but without intravascular overload, increasing the loop diuretic dose or adding a second diuretic may cause intravascular volume depletion, electrolyte disturbance, and worsening renal function without clearing the excess tissue fluid. COMPRESSION-HF tests whether adding lower limb compression to standard diuretic treatment improves early decongestion in patients with ADHF, predominant peripheral oedema, and inferior vena cava (IVC) diameter ≤21 mm.

methodsCOMPRESSION-HF (NCT06418932) is an investigator-initiated, multicentre, randomized, double-blind, sham-controlled trial in which adults with ADHF, bilateral leg oedema (grade II or higher of IV), N-terminal pro-B-type natriuretic peptide (NT-proBNP >1000 pg/ml), and IVC diameter ≤21 mm were assigned 1:1 to active bilateral lower limb compression (two-layer inelastic-elastic bandaging; manufacturer-specified nominal ankle pressure, approximately 20 mm Hg) plus parenteral furosemide or to sham bandaging plus parenteral furosemide, for up to 72 h. The two co-primary endpoints are 24-h urinary sodium excretion and change in body weight from baseline. Secondary endpoints include changes in lower limb circumference, clinical congestion score, and IVC diameter, together with NT-proBNP at 72 h, cumulative 72-h furosemide-equivalent dose, carbohydrate antigen 125 (CA-125) at day 15 ± 3, and 30-day safety. Continuous endpoints will be analysed with mixed-effects analysis of covariance or repeated-measures models including centre as a random intercept. Recruitment is complete (106 patients randomized); the trial was powered to detect a 20 mmol between-group difference in 24-h urinary sodium excretion.

conclusionsCOMPRESSION-HF will show whether adding lower limb compression to standard loop diuretic treatment increases natriuresis and weight loss in patients with ADHF and predominant peripheral oedema, and will describe the relationship between tissue congestion, intravascular refilling, and the diuretic response.