Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
NCT ID: NCT06418932
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
106 participants
INTERVENTIONAL
2024-05-27
2026-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Compressive
Compressive therapy of the lower limbs plus parenteral administration of diuretics
UrgoK2 / 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.
Control
Parenteral diuretics alone
Controll
Administration of parenteral diuretics only
Interventions
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UrgoK2 / 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.
Controll
Administration of parenteral diuretics only
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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COMPRESSION-HF
Identifier Type: -
Identifier Source: org_study_id
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