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

Fundación para la Investigación del Hospital Clínico de Valencia106 enrolled

Overview

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) plus a non-compressive sham bandage, versus parenteral administration of furosemide plus lower-limb compression therapy. The active compression bandage will be maintained for at least 24 hours and up to a maximum of 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Acute Decompensated Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Natriuresis

Natriuresis measured from a 24-hour urine collection starting at randomization.

Time frame: 24 hours after randomization

Weight

Changes in weight at 24 hours after randomization

Time frame: 24 hours

Secondary Outcomes

Diameter of the lower limbs

Changes in the diameter of the lower limbs (at 5 and 10 cm from the ankles) at 24 and 72 hours after randomization.

Time frame: 24 and 72 hours after randomization

Congestion score

Changes in clinical congestion score at 24 and 72 hours

Time frame: 24 and 72 hours after randomization

Inferior vena cava diameter

Changes in inferior vena cava diameter at 3, 24 and 72 hours

Time frame: 3, 24 and 72 hours after randomization

NT-proBNP

Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.

Time frame: 72 hours

CA125

Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days

Time frame: 15±3 days

Doses of furosemide

Dose of furosemide equivalents used during the first 72 hours after randomization.

Time frame: 72 hours

Time to oral administration.

Time to switch from diuretics to oral administration → lo dejaría, aunque en inglés queda algo más claro como Time to switch from parenteral to oral diuretic administration.

Time frame: 72 hours