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NCT Number: NCT06418932

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

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.

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Key information

Conditions

Acute Decompensated Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Denia, Denia, Alicante, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Controll

Other

Administration of parenteral diuretics only

Primary outcomes

  1. Natriuresis

    Time frame: 24 hours after randomization

    Natriuresis measured from a 24-hour urine collection starting at randomization.

  2. Weight

    Time frame: 24 hours

    Changes in weight at 24 hours after randomization

Secondary outcomes

  1. Diameter of the lower limbs

    Time frame: 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.

  2. Congestion score

    Time frame: 24 and 72 hours after randomization

    Changes in clinical congestion score at 24 and 72 hours

  3. Inferior vena cava diameter

    Time frame: 3, 24 and 72 hours after randomization

    Changes in inferior vena cava diameter at 3, 24 and 72 hours

  4. NT-proBNP

    Time frame: 72 hours

    Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.

  5. CA125

    Time frame: 15±3 days

    Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days

  6. Doses of furosemide

    Time frame: 72 hours

    Dose of furosemide equivalents used during the first 72 hours after randomization.

  7. Time to oral administration.

    Time frame: 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.

Other outcomes

  1. Tolerance

    Time frame: 24 and 72 hours after randomization

    Percentage of patients in whom tolerance of the compressive bandage is achieved at 24 and 72 hours

  2. eGFR

    Time frame: 72 hours

    Estimated glomerular filtration rate (eGFR) at 72 hours

  3. Electrolyte disturbances

    Time frame: 72 hours

    Electrolyte disturbances at 72 hours (hyponatremia: <135 mmo/l, hypernatremia>150 mmo/l, hypokalemia<3.5 mmo/l and hyperkalemia>5 mmo/l)

  4. Clinical adverse events

    Time frame: 30 days

    Clinical adverse events at 30 days total and cardiovascular, with special emphasis on cardiovascular death and HF decompensation

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 17, 2024
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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