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

NCT06418932 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-10-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418932 on ClinicalTrials.gov