Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: ControllDevice: UrgoK2 / UrgoK2 Lite
- Registration Number
- NCT06418932
- Lead Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Controll Parenteral diuretics alone Compressive UrgoK2 / UrgoK2 Lite Compressive therapy of the lower limbs plus parenteral administration of diuretics
- Primary Outcome Measures
Name Time Method Natriuresis 24 hours Changes in natriuresis at 24 hours after randomization.
Weight 24 hours Changes in weight at 24 hours after randomization
- Secondary Outcome Measures
Name Time Method CA125 15±3 days Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days
Doses of furosemide 72 hours Doses of furosemide equivalents used in the first 72 hours after randomization
Time to oral administration. 72 hours Time to switch from diuretics to oral administration
Diameter of the lower limbs 72 hours Changes in the diameter of the lower limbs (at 5 and 10 cm from the ankles) at 24 and 72 hours after randomization.
Congestion score 72 hours Changes in clinical congestion score at 24 and 72 hours
Inferior vena cava diameter 72 hours Changes in inferior vena cava diameter at 3, 24 and 72 hours
NT-proBNP 72 hours Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.
Trial Locations
- 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