RecruitingNot ApplicableNCT06418932

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


Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

106 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether applying compression therapy to the lower legs (like medical compression bandages or stockings) can help the body remove excess fluid more effectively in patients hospitalized with a sudden worsening of heart failure (acute decompensated heart failure) who have significant leg swelling. **You may be eligible if...** - You are 18 or older - You are being treated in hospital for acute (sudden, severe) worsening of heart failure, within the first 96 hours of starting IV diuretic (fluid-removing) treatment - You are receiving at least 40 mg of furosemide (a strong diuretic) in the past 24 hours - Your blood marker for heart stress (NT-proBNP) has been above 1000 pg/ml - You have significant lower leg swelling (at least grade II out of IV) - Your inferior vena cava (a large vein in the abdomen) measures 21 mm or less on ultrasound **You may NOT be eligible if...** - You are in an intensive care unit - You have had a kidney transplant, have severe chronic kidney failure, or are on dialysis - You have no pulse in your lower legs (absent peripheral pulses) - You have an ankle-brachial index below 0.9 (a sign of blocked blood flow to the legs) - You have severe peripheral artery disease - You have previously not tolerated compression bandaging - Your heart failure was caused by a recent heart attack Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUrgoK2 / 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.

OTHERControll

Administration of parenteral diuretics only


Locations(8)

Hospital de Denia

Denia, Alicante, Spain

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Puerta de Hierro

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital General de Valencia

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

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NCT06418932


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