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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: UrgoK2 / UrgoK2 Lite; Other: Controll

Study type: Interventional

Funder types: Other

Identifiers

NCT06418932

COMPRESSION-HF

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Compressive

Experimental group

Description:

Compressive therapy of the lower limbs plus parenteral administration of diuretics

Treatment:

Device: UrgoK2 / UrgoK2 Lite

Control

Active Comparator group

Description:

Parenteral diuretics alone

Treatment:

Other: Controll