Actively Recruiting
Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2024-10-21
106
Participants Needed
8
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older.
- Clinical judgment of acute decompensated heart failure within 96 hours from starting parenteral diuretic treatment.
- Treatment with at least 40 mg of furosemide in the last 24 hours.
- NT-proBNP levels greater than 1000 pg/ml at least once since decompensation began.
- Presence of tibio-malleolar edema at grade II/IV or higher at inclusion.
- Inferior vena cava diameter of 21 mm or less on ultrasonography at screening.
You will not qualify if you...
- Admission to the Intensive Care Unit.
- Renal transplant, chronic renal failure stage 5 (eGFR below 15 ml/min/1.73m2), dialysis, or need for ultrafiltration.
- Absence of peripheral pulses.
- Ankle brachial index below 0.9.
- History of severe peripheral artery disease.
- Previous intolerance to compressive bandaging.
- Heart failure caused by acute myocardial infarction.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Hospital de Denia
Denia, Alicante, Spain, 03700
Actively Recruiting
2
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain, 03186
Not Yet Recruiting
3
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Not Yet Recruiting
4
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
5
Hospital Puerta de Hierro
Madrid, Spain, 28222
Actively Recruiting
6
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
7
Hospital General de Valencia
Valencia, Spain, 46014
Actively Recruiting
8
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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