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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Clínico Universitario Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 168
Treatments
No_intervention: Standart of care treatment arm.
Loop diuretics (furosemide) will be administered intravenously according to stantard of care (Latest European heart failure guidelines)
Experimental: Treatment guided by intra-abdominal pressure values
Decongestive treatment will be adjusted according to intraabdominal pressure values (IAP) and/or point of care ultrasound:~Patients with IAP \< 8 mmHg (normal): The intravenous diuretic dose will be twice the patient's previous oral dose. If no diuretics were taken previously, 20 mg of furosemide will be administered every 12 hours.~Patients with IAP between 8 and 12 mmHg (moderately elevated): furosemide will be administered in combination with hydrochlorothiazide Patients wiht IAP \> 12: Furosemide will be initiated as a continuous infusion along with hydrochlorothiazide
Sponsors
Leads: Instituto de Investigación Sanitaria Aragón

This content was sourced from clinicaltrials.gov