## Protocol Section
### Identification Module
**NCT ID:** NCT06418932

**Brief Title:** 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

#### Organization Study ID Info
**ID:** COMPRESSION-HF
#### Organization
**Class:** OTHER
**Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia
### Status Module
#### Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundación para la Investigación del Hospital Clínico de Valencia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Heart Failure

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** 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.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 106

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Compressive therapy of the lower limbs plus parenteral administration of diuretics

**Intervention Names:**

- Device: UrgoK2 / UrgoK2 Lite

**Label:** Compressive

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Parenteral diuretics alone

**Intervention Names:**

- Other: Controll

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Compressive

**Description:** 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.

**Name:** UrgoK2 / UrgoK2 Lite

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** Administration of parenteral diuretics only

**Name:** Controll

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

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

**Measure:** Tolerance

**Time Frame:** 72 hours

**Description:** Estimated glomerular filtration rate (eGFR) at 72 hours

**Measure:** eGFR

**Time Frame:** 72 hours

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

**Measure:** Electrolyte disturbances

**Time Frame:** 72 hours

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

**Measure:** Clinical adverse events

**Time Frame:** 30 days

#### Primary Outcomes

**Description:** Changes in natriuresis at 24 hours after randomization.

**Measure:** Natriuresis

**Time Frame:** 24 hours

**Description:** Changes in weight at 24 hours after randomization

**Measure:** Weight

**Time Frame:** 24 hours

#### Secondary Outcomes

**Description:** Changes in the diameter of the lower limbs (at 5 and 10 cm from the ankles) at 24 and 72 hours after randomization.

**Measure:** Diameter of the lower limbs

**Time Frame:** 72 hours

**Description:** Changes in clinical congestion score at 24 and 72 hours

**Measure:** Congestion score

**Time Frame:** 72 hours

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

**Measure:** Inferior vena cava diameter

**Time Frame:** 72 hours

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

**Measure:** NT-proBNP

**Time Frame:** 72 hours

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

**Measure:** CA125

**Time Frame:** 15±3 days

**Description:** Doses of furosemide equivalents used in the first 72 hours after randomization

**Measure:** Doses of furosemide

**Time Frame:** 72 hours

**Description:** Time to switch from diuretics to oral administration

**Measure:** Time to oral administration.

**Time Frame:** 72 hours

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Email:** yulnunez@gmail.com

- **Name:** Julio JN Nuñez

- **Phone:** 652856689

- **Phone Ext:** +34

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Clínico Universitario de Valencia

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7411

- Name: Diuretics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
