Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure

Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion

Randomized 1:1 multicenter double-blind clinical investigation evaluating the efficacy and safety of compression therapy of the lower limbs plus parenteral administration of diuretics vs. administration of parenteral diuretics alone (standard treatment) in patients with decompensated HF and predominantly systemic tissue congestion and absence of intravascular systemic congestion.

Patients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for up to 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: UrgoK2 / UrgoK2 Lite; Other: Controll

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28222
    • Hospital Puerta de Hierro
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de la Arrixaca
  • Valencia, Spain, 46014
    • Hospital General de Valencia
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
  • Alicante
    • Denia, Alicante, Spain, 03700
      • Hospital de Denia
    • Torrevieja, Alicante, Spain, 03186
      • Hospital Universitario de Torrevieja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older.
• Patient with clinical judgment of acute decompensated heart failure in the first 96 hours from the start of parenteral diuretic treatment.
• Patient treated with furosemide at least 40 mg in the last 24 hours.
• NT-proBNP levels>1000 pg/ml at least 1 time since the onset of decompensation.
• Presence of tibio-malleolar edema at least grade II/IV at the time of inclusion.
• Inferior vena cava (IVC) diameter on ultrasonography ≤21 mm at the time of the "screening" visit.

Exclusion Criteria:

• Being admitted to the Intensive Care Unit.
• Renal transplant, chronic renal failure stage 5 (eGFR <15 ml/min/1.73m2) or being included in dialysis program (peritoneal/hemodialysis) or in need of ultrafiltration.
• Absence of peripheral pulses.
• Ankle brachial index (ABI) <0.9.
• History of severe peripheral artery disease.
• Previous intolerance to compressive bandaging.
• HF secondary to acute myocardial infarction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compressive; Compressive therapy of the lower limbs plus parenteral administration of diuretics	Device: UrgoK2 / UrgoK2 Lite; Multicomponent compressive bandage system consisting of an internal bandage of short traction and an external cohesive bandage of long traction, with pressure indicators on both bandages, which provides a sustained ankle pressure of ~20/40mmHg.
Active Comparator: Control; Parenteral diuretics alone	Other: Controll; Administration of parenteral diuretics only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natriuresis	Changes in natriuresis at 24 hours after randomization.	24 hours
Weight	Changes in weight at 24 hours after randomization	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter of the lower limbs	Changes in the diameter of the lower limbs (at 5 and 10 cm from the ankles) at 24 and 72 hours after randomization.	72 hours
Congestion score	Changes in clinical congestion score at 24 and 72 hours	72 hours
Inferior vena cava diameter	Changes in inferior vena cava diameter at 3, 24 and 72 hours	72 hours
NT-proBNP	Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.	72 hours
CA125	Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days	15±3 days
Doses of furosemide	Doses of furosemide equivalents used in the first 72 hours after randomization	72 hours
Time to oral administration.	Time to switch from diuretics to oral administration	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance	Percentage of patients in whom tolerance of the compressive bandage is achieved at 24 and 72 hours	72 hours
eGFR	Estimated glomerular filtration rate (eGFR) at 72 hours	72 hours
Electrolyte disturbances	Electrolyte disturbances at 72 hours (hyponatremia: <135 mmo/l, hypernatremia>150 mmo/l, hypokalemia<3.5 mmo/l and hyperkalemia>5 mmo/l)	72 hours
Clinical adverse events	Clinical adverse events at 30 days total and cardiovascular, with special emphasis on cardiovascular death and HF decompensation	30 days

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: COMPRESSION-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No