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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compressive | Experimental | Compressive therapy of the lower limbs plus parenteral administration of diuretics |
|
| Control | Active Comparator | Parenteral diuretics alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UrgoK2 / UrgoK2 Lite | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Natriuresis | Changes in natriuresis at 24 hours after randomization. | 24 hours |
| Weight | Changes in weight at 24 hours after randomization | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Congestion score | Changes in clinical congestion score at 24 and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Percentage of patients in whom tolerance of the compressive bandage is achieved at 24 and 72 hours | 72 hours |
| eGFR | Estimated glomerular filtration rate (eGFR) at 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Denia | Denia | Alicante | 03700 | Spain | ||
| Hospital Universitario de Torrevieja |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 a maximum of 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible health professional.
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Sham procedure. Blinded to treatment allocation. The investigator and the patients will be blinded to treatment assignments. For this purpose, a restraint system will be used which will be applied to the lower limbs and will mask the assignment.
| Controll | Other | Administration of parenteral diuretics only |
|
| 72 hours |
| Inferior vena cava diameter | Changes in inferior vena cava diameter at 3, 24 and 72 hours | 72 hours |
| NT-proBNP | Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours. | 72 hours |
| CA125 | Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days | 15±3 days |
| Doses of furosemide | Doses of furosemide equivalents used in the first 72 hours after randomization | 72 hours |
| Time to oral administration. | Time to switch from diuretics to oral administration | 72 hours |
| 72 hours |
| Electrolyte disturbances | Electrolyte disturbances at 72 hours (hyponatremia: <135 mmo/l, hypernatremia>150 mmo/l, hypokalemia<3.5 mmo/l and hyperkalemia>5 mmo/l) | 72 hours |
| Clinical adverse events | Clinical adverse events at 30 days total and cardiovascular, with special emphasis on cardiovascular death and HF decompensation | 30 days |
| Torrevieja |
| Alicante |
| 03186 |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Spain |