Clinical trial NCT07008365: The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
Official title: The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Heart Failure
Congestive Heart Failure
Intraabdominal Hypertension
Cardio-Renal Syndrome
Keywords: Point of care Ultrasound (POCUS)
Acute Heart Failure
Cardio-renal syndrome
Intraabdominal pressure
Diuretic treatment
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After conducting an initial comprehensive evaluation and confirming the inclusion and exclusion criteria, along with obtaining the necessary informed consent (screening), the patient will be randomized within the first 24 hours of admission into one of the two treatment groups with the aim of determining whether a diuretic treatment strategy based on intra-abdominal pressure and clinical ultrasound is superior to the conventional diuretic treatment strategy for resolving systemic congestion after the first 72 hours of admission.
Primary purpose: TREATMENT

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) \&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.

Primary outcomes:
measure: Significant reduction in congestion (ADVOR scale)
timeFrame: After the first 72 hours of endovenous loop diuretic treatment
Secondary outcomes:
measure: Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines)
timeFrame: From time to randomization until the first 72 hours of endovenous loop diuretics treatment at the Internal Medicine ward
measure: Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score)
timeFrame: After the first 72 hours of endovenous loop diuretic treatment
measure: Total diuresis response
timeFrame: After the first 72 hours of endovenous loop diuretic treatment
measure: Total dose of diuretic treatment
timeFrame: After the first 72 hours of endovenous loop diuretic treatment
measure: Number of patients treated for worsening heart failure
timeFrame: From date of discharge until 30-days post-hospitalization visit. From date of discharge until 90-days post-hospitalization visit. (cut-off period 1-year)
measure: Total number of patients with cardiovascular death
timeFrame: From date of discharge until the date of cardiovascular death (cut-off period 1 year)
measure: guided directed medical therapy (GDMT)
timeFrame: From date of admission up to discharge, from date of discharge up to 30 days after and from date of discharge up to 90 days (cut-off period 1-year)
measure: length of stay
timeFrame: From date of randomization until date of discharge (cut-off period 4 weeks)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
References: