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

RecruitingPhase 3Ages 18 Years - 100 YearsAllInstituto de Investigación Sanitaria Aragón
NCT07008365 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Car

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📋 Eligibility rules (as published)
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.
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What it tests

  • Furosemide 20 Milligrams
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Where

2 sites
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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