Acute Decompensated Heart Failure
Conditions
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) 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.
Interventions
DEVICEUrgoK2 / 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.
OTHERControll
Administration of parenteral diuretics only
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and blinded investigators will be unaware of treatment allocation. In the control arm, a non-compressive sham bandage will be applied to the lower limbs. The active and sham bandages are designed so that there are no differences on visual inspection by the blinded investigators.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Natriuresis | 24 hours after randomization | Natriuresis measured from a 24-hour urine collection starting at randomization. |
| Weight | 24 hours | Changes in weight at 24 hours after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diameter of the lower limbs | 24 and 72 hours after randomization | 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 | 24 and 72 hours after randomization | Changes in clinical congestion score at 24 and 72 hours |
| Inferior vena cava diameter | 3, 24 and 72 hours after randomization | 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. |
| CA125 | 15±3 days | Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days |
| Doses of furosemide | 72 hours | Dose of furosemide equivalents used during the first 72 hours after randomization. |
| Time to oral administration. | 72 hours | 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. |
Countries
Spain
Outcome results
None listed