Using intra‑abdominal pressure and bedside ultrasound to guide decongestive treatment in heart failure

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

This trial will test whether using bladder pressure (intra‑abdominal pressure) measurements together with bedside ultrasound to guide IV loop diuretics helps people hospitalized with acute heart failure get rid of excess fluid more effectively than usual care.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria Aragón (Academic / other)
• Locations: 2 sites (Zaragoza and 1 other locations)
• Trial ID: NCT07008365 on ClinicalTrials.gov

What this trial studies

This is a randomized, multicenter Phase 3 trial enrolling adults admitted with acute heart failure and clinical signs of congestion. Participants must have elevated natriuretic peptides and a urinary catheter to allow intra‑abdominal pressure measurement, and they are randomized to diuretic dosing guided by intra‑abdominal pressure plus point‑of‑care ultrasound versus conventional care. The intervention uses serial intra‑abdominal pressure readings and focused ultrasound findings to tailor intravenous loop diuretic (furosemide) dosing during the hospital stay. The trial is led by Instituto de Investigación Sanitaria Aragón with enrollment at Hospital Clínico Universitario Lozano Blesa in Zaragoza, Spain.

Who should consider this trial

Good fit: Adults (≥18) hospitalized with acute heart failure who have elevated NT‑proBNP/BNP, clinical signs of congestion, and who can have a urinary catheter placed are the ideal candidates.

Not a fit: Patients without sufficient clinical congestion, those who cannot have a urinary catheter placed, or those with cardiogenic shock, severe hypotension, or extreme tachycardia are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help more patients leave hospital with less fluid overload and lower risk of early readmission.

How similar studies have performed: Prior work has shown promise for ultrasound‑guided decongestion, but using intra‑abdominal pressure to guide diuretic dosing is relatively novel and not yet widely tested in large Phase 3 trials.

Eligibility criteria

Inclusion Criteria:

* 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) \> 1000 pg/mL or Brain Natriuretic Peptide (BNP) \> 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

Exclusion Criteria:

* Patient with a stay in the Internal Medicine department \> 24 hours.
* Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization).
* Patient\'s refusal to participate in the clinical trial.
* Inability or contraindication for urinary catheter placement.
* Systolic blood pressure at admission \< 100 mmHg.
* Heart rate at admission \> 170 beats per minute (bpm).
* Cardiogenic shock.
* Acute myocardial ischemia.
* Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
* Kidney transplant recipients.
* Serum hemoglobin \< 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.
* Need for inotropic support to maintain adequate cardiac and/or renal output.

Where this trial is running

Zaragoza and 1 other locations

• Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
• Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain (Not_yet_recruiting)

Conditions Acute Heart Failure; Congestive Heart Failure; Intraabdominal Hypertension; Cardio-Renal Syndrome; Point of care Ultrasound; Cardio-renal syndrome; Intraabdominal pressure; Diuretic treatment