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

Heart Failure

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

Inclusion Criteria6

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 Criteria7

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.

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