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Recruiting Phase 3 NCT07008365

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

Trial Parameters

Condition Acute Heart Failure
Sponsor Instituto de Investigación Sanitaria Aragón
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 168
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2025-03-10
Completion 2026-11-30
Interventions
Furosemide 20 Milligrams

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.

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

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