Journal Article Ahead of print
PubMed: 42583743 DOI: 10.1093/eschf/xvag214
Lower-limb compression in AHF and predominant tissue congestion: rationale and design of the COMPRESSION-HF trial.
ESC Heart Fail
Authors: José Manuel Civera, Elena Chover, Patricia Castro, José Pérez Silvestre, David García Escrivá, Pau Llàcer, Esteban Pérez Pisón, Marta Cobo Marcos, Juan Carlos López Azor, Francisco Pastor Pérez, Amparo Martínez López, Clara Simón Ramón, Alba Villalobos Abelló, Julio Núñez, Rafael de la Espriella
Affiliations
- Cardiology Department. Hospital Clínico Universitario de Valencia, INCLIVA, Valencia, Spain.
- Internal Medicine Department. Hospital General Universitario de Valencia, Valencia, Spain.
- Nursing Department. Universitat de València, Valencia, Spain.
- Internal Medicine Department. Hospital Universitario Ramón y Cajal, Madrid, Spain.
- Cardiology Department. Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.
- Cardiology Department. Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
- Cardiology Department. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
- Department of Medicine. Universitat de València, Valencia, Spain.
- CIBER Cardiovascular, Madrid, Spain.
- Cardiology Department. Hospital Clínico Universitario de Valencia, INCLIVA, Valencia, Spain. CIBER Cardiovascular, Madrid, Spain.
Abstract
AIMS
. Acute 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 rehospitalisation 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 diameter ≤21 mm.
METHODS
. COMPRESSION-HF (NCT06418932) is an investigator-initiated, multicentre, randomised, double-blind, sham-controlled trial in which adults with ADHF, bilateral leg oedema (≥grade II/IV), NT-proBNP >1000 pg/mL, and inferior vena cava (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 mmHg) 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, CA-125 at day 15 ± 3, and 30-day safety. Continuous endpoints will be analysed with mixed-effects ANCOVA or repeated-measures models including centre as a random intercept. Recruitment is complete (106 patients randomised); the trial was powered to detect a 20 mmol between-group difference in 24-h urinary sodium excretion.
CONCLUSIONS
COMPRESSION-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.
MeSH
Heart Failure, Vena Cava, Inferior, Natriuresis, Diuretics, Therapeutics, Furosemide, Tissues