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

NCT06418932 | Recruiting

• 1 other identifier: COMPRESSION-HF
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 8

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Natriuresis

  Changes in natriuresis at 24 hours after randomization.

  24 hours

• Weight

  Changes in weight at 24 hours after randomization

  24 hours

Secondary Outcomes (7)

• Diameter of the lower limbs

  72 hours

• Congestion score

  72 hours

• Inferior vena cava diameter

  72 hours

• NT-proBNP

  72 hours

• CA125

  15±3 days

Other Outcomes (4)

• Tolerance

  72 hours

• eGFR

  72 hours

• Electrolyte disturbances

  72 hours

Study Arms (2)

Compressive

EXPERIMENTAL

Compressive therapy of the lower limbs plus parenteral administration of diuretics

Device: UrgoK2 / UrgoK2 Lite

Control

ACTIVE COMPARATOR

Parenteral diuretics alone

Other: Controll

Interventions

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.

Compressive

Controll OTHER

Administration of parenteral diuretics only

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Inferior vena cava (IVC) diameter on ultrasonography ≤21 mm at the time of the "screening" visit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (8)

Hospital de Denia

Denia, Alicante, 03700, Spain

RECRUITING

Hospital Universitario de Torrevieja

Torrevieja, Alicante, 03186, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Puerta de Hierro

Madrid, 28222, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital General de Valencia

Valencia, 46014, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: May 27, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)