Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07008365

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Heart Failure Cardio-Renal Syndrome Cardiovascular Diseases Compartment Syndromes Congestive Heart Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Intra-Abdominal Hypertension Intraabdominal Hypertension Kidney Diseases Male Urogenital Diseases Muscular Diseases Musculoskeletal Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 myocardial ischemia.
  • Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
  • Kidney transplant recipients.
  • Serum hemoglobin < 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.

Treatment and study plan

Furosemide 20 Milligrams

Drug

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

Other names: furosemide 500 milligrams, hydrochlorothiazide 25 milligrams

Primary outcomes

  1. Significant reduction in congestion (ADVOR scale)

    Time frame: After the first 72 hours of endovenous loop diuretic treatment

    To evaluate the significant reduction in congestion (ADVOR Scale) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound).

    ADVOR Scale:

    Oedema: No oedema (0 points), Trace oedema (1 point), Clear pitting oedema (2 points), Visual deformation above ankle (3 points), Visual deformation above knee (4 points).

    Pleural effusion: No pleural effusion (0 points), Minor (2 points), Major (3 points)

    Ascites: No ascites (0 points), Minor ascites (2 points), Significant ascites (3 points)

    TOTAL SCORE: Oedema score + Pleural effusion + Ascitis. Minimum 0 points; Maximum 10 points

Secondary outcomes

  1. Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines)

    Time frame: From time to randomization until the first 72 hours of endovenous loop diuretics treatment at the Internal Medicine ward

    To evaluate the complete resolution of pulmonary congestion as assessed by ultrasound (B-lines) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound).

    The degree of pulmonary tissue congestion will be quantified using clinical ultrasound. Eight quadrants (four left and four right) will be examined. A quadrant will be considered positive for pulmonary tissue congestion if three or more B-lines are detected. Minimum: 0 quadrants; Maximum 8 quadrants

  2. Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score)

    Time frame: After the first 72 hours of endovenous loop diuretic treatment

    To evaluate the significant reduction in intravascular congestion (inferior vena cava diameter and venous excess ultrasound protocol) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound).

    VEXUS score

    • Grade 0: No congestion; inferior vena cava vein (IVC) diameter < 2 cms
    • Grade 1: Mild congestion, IVC 2> cms + any combination of normal or mildly abnormal waveforms of doppler veins explored.
    • Grade 2: Moderate congestion, IVC > 2 cms + at least one severely abnormal pattern of doppler veins explored.
    • Grade 3: Severe congestion, IVC > 2cms + two or more severely abnormal waveforms of doppler veins explored.

    Minimum 0 points; Maximum 3 points

  3. Total diuresis response

    Time frame: After the first 72 hours of endovenous loop diuretic treatment

    To evaluate the diuretic response (total urine volume/total dose of furosemide administered) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound).

  4. Total dose of diuretic treatment

    Time frame: After the first 72 hours of endovenous loop diuretic treatment

    To compare the days and doses of intravenous loop diuretics and hydrochlorothiazide used during the first 72 hours of hospitalization between the standard treatment group and the intervention group.

  5. Number of patients treated for worsening heart failure

    Time frame: 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)

    Differences in heart failure worsening (defined as the need for intravenous loop diuretic treatment after hospital discharge, whether in a day hospital, emergency department, or due to new hospital admissions at 30 and 90 days) between the two groups.

  6. Total number of patients with cardiovascular death

    Time frame: From date of discharge until the date of cardiovascular death (cut-off period 1 year)

    Differences in cardiovascular death incidence

  7. guided directed medical therapy (GDMT)

    Time frame: 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)

    Prevalence of GDMT prescribed at discharge according to left ventricular ejection fraction and actual heart failure guidelines

  8. length of stay

    Time frame: From date of randomization until date of discharge (cut-off period 4 weeks)

    Differences in length of stay between both arms

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Aragón

Other

Registry information

Acronym: ABDOPOCUS-HF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.