RecruitingPhase 3NCT07008365

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


Sponsor

Instituto de Investigación Sanitaria Aragón

Enrollment

168 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether monitoring abdominal pressure and using bedside ultrasound to guide diuretic treatment (water pills) can lead to better outcomes in hospitalized patients with heart failure who have fluid overload. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of heart failure - Your heart failure markers (BNP or NT-proBNP) are significantly elevated - You have signs of fluid overload (leg swelling, fluid in the abdomen or lungs) - You have a urinary catheter in place **You may NOT be eligible if...** - You have been in the hospital for more than 24 hours before enrollment - Your blood pressure is too low at admission (under 100 mmHg systolic) - Your heart rate is extremely high (over 170 bpm) - You are in cardiogenic shock or have acute heart attack - You are on dialysis or have had a kidney transplant - Your hemoglobin is below 9 g/dL - You are pregnant or breastfeeding - You have had heart surgery or a heart transplant in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFurosemide 20 Milligrams

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


Locations(2)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

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NCT07008365


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