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Search / Trial NCT07008365

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

Launched by INSTITUTO DE INVESTIGACIÓN SANITARIA ARAGÓN · Jun 4, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Point Of Care Ultrasound (Pocus) Acute Heart Failure Cardio Renal Syndrome Intraabdominal Pressure Diuretic Treatment

ClinConnect Summary

This clinical trial is studying a new way to guide treatment for patients with acute heart failure, a serious condition where the heart struggles to pump blood effectively. Researchers want to see if using measurements of pressure in the abdomen and ultrasound imaging can help doctors give the right amount of diuretics (medications that help remove excess fluid) more effectively than the usual methods. The goal is to reduce symptoms of congestion, which can make patients feel uncomfortable and unwell.

To participate in this study, you must be an adult with a diagnosed heart failure and show certain signs of fluid overload. This includes having a specific level of a heart-related substance in your blood and needing a urinary catheter to measure abdominal pressure. If you join the trial, you’ll be randomly assigned to one of two groups: one will receive treatment based on standard practices, while the other will have treatment guided by the new methods for the first 72 hours of hospitalization. Participants will be monitored closely to assess their response to the treatment. This trial is currently recruiting and aims to improve care for those facing heart failure.

Gender

ALL

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.

About Instituto De Investigación Sanitaria Aragón

Instituto de Investigación Sanitaria Aragón (IIS Aragón) is a leading clinical research organization dedicated to advancing healthcare through innovative research and collaboration. Based in Spain, IIS Aragón focuses on translational medicine, bridging the gap between laboratory discoveries and clinical applications. The institute fosters a multidisciplinary approach, bringing together experts from various fields to enhance the quality and efficiency of clinical trials. With a commitment to ethical standards and patient safety, IIS Aragón plays a pivotal role in driving scientific advancements and improving health outcomes in the region and beyond.

Locations

Zaragoza, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported