Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure

Heart Failure Clinical Trial

Official title:

Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418932
• Other study ID #: COMPRESSION-HF
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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.

Other:
• Controll
Administration of parenteral diuretics only

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerance	Percentage of patients in whom tolerance of the compressive bandage is achieved at 24 and 72 hours	72 hours
Other	eGFR	Estimated glomerular filtration rate (eGFR) at 72 hours	72 hours
Other	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
Other	Clinical adverse events	Clinical adverse events at 30 days total and cardiovascular, with special emphasis on cardiovascular death and HF decompensation	30 days
Primary	Natriuresis	Changes in natriuresis at 24 hours after randomization.	24 hours
Primary	Weight	Changes in weight at 24 hours after randomization	24 hours
Secondary	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
Secondary	Congestion score	Changes in clinical congestion score at 24 and 72 hours	72 hours
Secondary	Inferior vena cava diameter	Changes in inferior vena cava diameter at 3, 24 and 72 hours	72 hours
Secondary	NT-proBNP	Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.	72 hours
Secondary	CA125	Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days	15±3 days
Secondary	Doses of furosemide	Doses of furosemide equivalents used in the first 72 hours after randomization	72 hours
Secondary	Time to oral administration.	Time to switch from diuretics to oral administration	72 hours