Acute Decompensated Heart FailureNCT06418932
Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
A study testing UrgoK2 / UrgoK2 Lite in people with Acute Decompensated Heart Failure, run by Fundación para la Investigación del Hospital Clínico de Valencia at 8 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- UrgoK2 / UrgoK2 Lite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 8 sitesSpain
- Study dates
- 27 May 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital de Denia
Denia, Alicante, 03700
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Puerta de Hierro
Madrid, 28222
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186
Hospital General de Valencia
Valencia, 46014
Hospital Clínico Universitario de Valencia
Valencia
About this study
Official title: Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion
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.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- UrgoK2 / UrgoK2 Lite, Controll
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrgoK2 / UrgoK2 LiteDevice
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.
ControllOther
Administration of parenteral diuretics only
| Study group | Role | What they receive |
|---|---|---|
| Compressive | Experimental | Compressive therapy of the lower limbs plus parenteral administration of diuretics Receives: Device: UrgoK2 / UrgoK2 Lite |
| Control: Standard treatment + sham bandage | Active comparator | Parenteral administration of furosemide plus a non-compressive sham bandage applied to the lower limbs. The sham bandage consists of a Vendari SOFTPAD® padding bandage and a Vendari DARIFLEX® tubular bandage and is changed every 24 hours. Receives: Other: Controll |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natriuresis
Natriuresis measured from a 24-hour urine collection starting at randomization.
Measured: 24 hours after randomization
Weight
Changes in weight at 24 hours after randomization
Measured: 24 hours
Secondary outcomes (7)
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.
Measured: 24 and 72 hours after randomization
Congestion score
Changes in clinical congestion score at 24 and 72 hours
Measured: 24 and 72 hours after randomization
Inferior vena cava diameter
Changes in inferior vena cava diameter at 3, 24 and 72 hours
Measured: 3, 24 and 72 hours after randomization
NT-proBNP
Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.
Measured: 72 hours
CA125
Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days
Measured: 15±3 days
Doses of furosemide
Dose of furosemide equivalents used during the first 72 hours after randomization.
Measured: 72 hours
Time to oral administration.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start27 May 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418932
- Sponsor's protocol ID
- COMPRESSION-HF
- Status last verified
- Sep 2026
- First submitted
- 13 May 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion
- ClinicalTrials.gov ID
- NCT06418932
- Acronym / sponsor ID
- COMPRESSION-HF
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Compressive | Experimental | Device: UrgoK2 / UrgoK2 LiteCompressive therapy of the lower limbs plus parenteral administration of diuretics |
| Control: Standard treatment + sham bandage | Active comparator | Other: ControllParenteral administration of furosemide plus a non-compressive sham bandage applied to the lower limbs. The sham bandage consists of a Vendari SOFTPAD® padding bandage and a Vendari DARIFLEX® tubular bandage and is changed every 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrgoK2 / UrgoK2 LiteMulticomponent 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. | Device | Compressive |
| ControllAdministration of parenteral diuretics only | Other | Control: Standard treatment + sham bandage |
Primary outcome
Natriuresis
Time frame: 24 hours after randomization
Natriuresis measured from a 24-hour urine collection starting at randomization.
Weight
Time frame: 24 hours
Changes in weight at 24 hours after randomization
7 secondary outcomes
Diameter of the lower limbs
Time frame: 24 and 72 hours after randomization
Congestion score
Time frame: 24 and 72 hours after randomization
Inferior vena cava diameter
Time frame: 3, 24 and 72 hours after randomization
NT-proBNP
Time frame: 72 hours
CA125
Time frame: 15±3 days
Doses of furosemide
Time frame: 72 hours
Time to oral administration.
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UrgoK2 / UrgoK2 Lite in people with Acute Decompensated Heart Failure, run by Fundación para la Investigación del Hospital Clínico de Valencia at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natriuresis (time frame: 24 hours after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.