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

NCT ID: NCT07008365

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-12-31

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.

Conditions

Acute Heart Failure; Congestive Heart Failure; Intraabdominal Hypertension; Cardio-Renal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standart of care treatment arm.

Loop diuretics (furosemide) will be administered intravenously according to stantard of care (Latest European heart failure guidelines)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Furosemide 20 Milligrams

Intervention Type: DRUG

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

Interventions

Furosemide 20 Milligrams

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

Intervention Type: DRUG

Other Intervention Names

furosemide 500 milligrams; hydrochlorothiazide 25 milligrams

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) &gt; 1000 pg/mL or Brain Natriuretic Peptide (BNP) &gt; 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 &gt; 24 hours.
• Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization).
• Patient&#39;s refusal to participate in the clinical trial.
• Inability or contraindication for urinary catheter placement.
• Systolic blood pressure at admission &lt; 100 mmHg.
• Heart rate at admission &gt; 170 beats per minute (bpm).
• Cardiogenic shock.
• Acute myocardial ischemia.
• Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
• Kidney transplant recipients.
• Serum hemoglobin &lt; 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status: RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Facility Contacts

Jorge Rubio-Gracia, M.D.PhD

Role: primary

jorgerubiogracia@gmail.com

+34649839735

Jorge Rubio-Gracia, MD.PhD

Role: primary

jorgerubiogracia@gmail.com

+34649839735

Related Links

https://reec.aemps.es/reec/public/detail.html

Website of the Spanish Medicines Agency where the clinical trial is registered in clinical trial information system (CTIS)

Other Identifiers

PI23/00797

Identifier Type: -

Identifier Source: org_study_id