Clinical trial NCT06418932: Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
Official title: Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Natriuresis
timeFrame: 24 hours
measure: Weight
timeFrame: 24 hours
Secondary outcomes:
measure: Diameter of the lower limbs
timeFrame: 72 hours
measure: Congestion score
timeFrame: 72 hours
measure: Inferior vena cava diameter
timeFrame: 72 hours
measure: NT-proBNP
timeFrame: 72 hours
measure: CA125
timeFrame: 15±3 days
measure: Doses of furosemide
timeFrame: 72 hours
measure: Time to oral administration.
timeFrame: 72 hours
Other outcomes:
measure: Tolerance
timeFrame: 72 hours
measure: eGFR
timeFrame: 72 hours
measure: Electrolyte disturbances
timeFrame: 72 hours
measure: Clinical adverse events
timeFrame: 30 days
Locations:
city: Denia
country: Spain
facility: Hospital de Denia
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References: