NCT06418932

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.
OTHER	Controll	Administration of parenteral diuretics only

Timeline

• Start date: 2024-05-27
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-05-17
• Last updated: 2024-10-21

Locations

8 sites across 1 country: Spain