The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure

NCT07008365 | Recruiting Phase 3 DMC

• 1 other identifier: PI23/00797
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

Systemic venous congestion is the primary therapeutic target of intravenous loop diuretics in patients admitted for acute heart failure (AHF). Despite their utility, a significant proportion of AHF patients are discharged with persistent clinical symptoms of congestion (residual congestion). Therefore, in recent years, there has been a growing focus on the use of tools (biomarkers, clinical ultrasound) that allow us to optimize diuretic treatment and thereby improve the prognosis of AHF patients. The objective is to analyze whether the strategy of guiding intravenous loop diuretic dosing based on intra-abdominal pressure(IAP) measurements and clinical ultrasound is superior to the conventional strategy employed in daily clinical practice. This study is a randomized, multicenter clinical trial involving consecutive patients admitted with a diagnosis of AHF in the Internal Medicine and Cardiology departments. Patients who meet the inclusion criteria, after signing informed consent, will be randomized into two groups: 1) Diuretic treatment guided by usual clinical practice and 2) Treatment guided by intra-abdominal pressure levels and clinical ultrasound (inferior vena cava and portal Doppler). This strategy will be maintained during the first 72 hours of admission, with a thorough analysis of congestion and diuretic response being conducted.

Conditions

Acute Heart Failure; Congestive Heart Failure; Intraabdominal Hypertension; Cardio-Renal Syndrome

Keywords

Point of care Ultrasound (POCUS); Acute Heart Failure; Cardio-renal syndrome; Intraabdominal pressure; Diuretic treatment

Outcome Measures

Primary Outcomes (1)

• Significant reduction in congestion (ADVOR scale)

  To evaluate the significant reduction in congestion (ADVOR Scale) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound). ADVOR Scale: Oedema: No oedema (0 points), Trace oedema (1 point), Clear pitting oedema (2 points), Visual deformation above ankle (3 points), Visual deformation above knee (4 points). Pleural effusion: No pleural effusion (0 points), Minor (2 points), Major (3 points) Ascites: No ascites (0 points), Minor ascites (2 points), Significant ascites (3 points) TOTAL SCORE: Oedema score + Pleural effusion + Ascitis. Minimum 0 points; Maximum 10 points

  After the first 72 hours of endovenous loop diuretic treatment

Secondary Outcomes (8)

• Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines)

  From time to randomization until the first 72 hours of endovenous loop diuretics treatment at the Internal Medicine ward

• Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score)

  After the first 72 hours of endovenous loop diuretic treatment

• Total diuresis response

  After the first 72 hours of endovenous loop diuretic treatment

• Total dose of diuretic treatment

  After the first 72 hours of endovenous loop diuretic treatment

• Number of patients treated for worsening heart failure

  From date of discharge until 30-days post-hospitalization visit. From date of discharge until 90-days post-hospitalization visit. (cut-off period 1-year)

Study Arms (2)

Standart of care treatment arm.

NO INTERVENTION

Loop diuretics (furosemide) will be administered intravenously according to stantard of care (Latest European heart failure guidelines)

Treatment guided by intra-abdominal pressure values

EXPERIMENTAL

Decongestive treatment will be adjusted according to intraabdominal pressure values (IAP) and/or point of care ultrasound: Patients with IAP \< 8 mmHg (normal): The intravenous diuretic dose will be twice the patient's previous oral dose. If no diuretics were taken previously, 20 mg of furosemide will be administered every 12 hours. Patients with IAP between 8 and 12 mmHg (moderately elevated): furosemide will be administered in combination with hydrochlorothiazide Patients wiht IAP \> 12: Furosemide will be initiated as a continuous infusion along with hydrochlorothiazide

Drug: Furosemide 20 Milligrams

Interventions

Furosemide 20 Milligrams DRUG

Decongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound

Also known as: furosemide 500 milligrams, hydrochlorothiazide 25 milligrams

Treatment guided by intra-abdominal pressure values

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over 18 years of age.
• Diagnosis of heart failure (HF) based on the latest HF guidelines published in 2022.
• N-terminal pro b-type natriuretic peptide (NT-proBNP) \&gt; 1000 pg/mL or Brain Natriuretic Peptide (BNP) \&gt; 250 pg/mL.
• Placement of a urinary catheter to allow for the measurement of intra-abdominal pressure.
• Intravascular or mixed congestion pattern, defined as the presence of one or more clinical signs of congestion (edema, ascites, and/or pleural effusion).
• Signed informed consent

You may not qualify if:

• Patient with a stay in the Internal Medicine department \&gt; 24 hours.
• Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization).
• Patient\&#39;s refusal to participate in the clinical trial.
• Inability or contraindication for urinary catheter placement.
• Systolic blood pressure at admission \&lt; 100 mmHg.
• Heart rate at admission \&gt; 170 beats per minute (bpm).
• Cardiogenic shock.
• Acute myocardial ischemia.
• Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
• Kidney transplant recipients.
• Serum hemoglobin \&lt; 9 g/dL.
• Pregnancy or breastfeeding.
• History of hypersensitivity to hydrochlorothiazide or furosemide.
• Patients admitted from the Intensive Care Unit.
• Patients with recent cardiac surgery (within the last year) or heart transplant recipients.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (2)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50008, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

NOT YET RECRUITING

Related Links

• Website of the Spanish Medicines Agency where the clinical trial is registered in clinical trial information system (CTIS)

MeSH Terms

Conditions

Heart Failure; Intra-Abdominal Hypertension; Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After conducting an initial comprehensive evaluation and confirming the inclusion and exclusion criteria, along with obtaining the necessary informed consent (screening), the patient will be randomized within the first 24 hours of admission into one of the two treatment groups with the aim of determining whether a diuretic treatment strategy based on intra-abdominal pressure and clinical ultrasound is superior to the conventional diuretic treatment strategy for resolving systemic congestion after the first 72 hours of admission.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: June 6, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2024-08

Locations

ES (2)