Acute Heart FailurePhase 3ABDOPOCUS-HFNCT07008365
The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
A Phase 3 study testing Furosemide 20 Milligrams in people with Acute Heart Failure and Congestive Heart Failure, run by Instituto de Investigación Sanitaria Aragón at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Heart Failure, Congestive Heart Failure, Intraabdominal Hypertension
- What is being tested?
- Furosemide 20 Milligrams
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Mar 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50008
Jorge Rubio-Gracia, M.D.PhD, +34649839735, jorgerubiogracia@gmail.com
- Not yet recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Jorge Rubio-Gracia, MD.PhD, +34649839735, jorgerubiogracia@gmail.com
Marta Sanchez-Marteles, MD.PhD
About this study
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
- Being tested
- Furosemide 20 Milligrams
- Keywords
- Point of care Ultrasound (POCUS), Acute Heart Failure, Cardio-renal syndrome, Intraabdominal pressure, Diuretic treatment
- Medical subject headings
- Heart Failure, Intra-Abdominal Hypertension, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 20 MilligramsDrug
Also called furosemide 500 milligrams, hydrochlorothiazide 25 milligrams
Decongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Standart of care treatment arm. | No intervention | Loop diuretics (furosemide) will be administered intravenously according to stantard of care (Latest European heart failure guidelines) |
| Treatment guided by intra-abdominal pressure values | Experimental | 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 Receives: Drug: Furosemide 20 Milligrams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction in congestion (ADVOR scale)
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
Measured: After the first 72 hours of endovenous loop diuretic treatment
Secondary outcomes (8)
Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines)
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
Measured: From time to randomization until the first 72 hours of endovenous loop diuretics treatment at the Internal Medicine ward
Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score)
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
Measured: After the first 72 hours of endovenous loop diuretic treatment
Total diuresis response
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).
Measured: After the first 72 hours of endovenous loop diuretic treatment
Total dose of 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.
Measured: After the first 72 hours of endovenous loop diuretic treatment
Number of patients treated for worsening heart failure
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.
Measured: 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)
Total number of patients with cardiovascular death
Differences in cardiovascular death incidence
Measured: From date of discharge until the date of cardiovascular death (cut-off period 1 year)
guided directed medical therapy (GDMT)
Prevalence of GDMT prescribed at discharge according to left ventricular ejection fraction and actual heart failure guidelines
Measured: 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)
length of stay
Differences in length of stay between both arms
Measured: From date of randomization until date of discharge (cut-off period 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start10 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008365
- Sponsor's protocol ID
- PI23/00797
- Acronym
- ABDOPOCUS-HF
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
- ClinicalTrials.gov ID
- NCT07008365
- Acronym / sponsor ID
- ABDOPOCUS-HF / PI23/00797
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standart of care treatment arm. | No intervention | –Loop diuretics (furosemide) will be administered intravenously according to stantard of care (Latest European heart failure guidelines) |
| Treatment guided by intra-abdominal pressure values | Experimental | Drug: Furosemide 20 MilligramsDecongestive 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide 20 MilligramsAlso: furosemide 500 milligrams, hydrochlorothiazide 25 milligramsDecongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound | Drug | Treatment guided by intra-abdominal pressure values |
Primary outcome
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
8 secondary outcomes
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
Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score)
Time frame: After the first 72 hours of endovenous loop diuretic treatment
Total diuresis response
Time frame: After the first 72 hours of endovenous loop diuretic treatment
Total dose of diuretic treatment
Time frame: After the first 72 hours of endovenous loop diuretic treatment
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)
Total number of patients with cardiovascular death
Time frame: From date of discharge until the date of cardiovascular death (cut-off period 1 year)
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)
length of stay
Time frame: From date of randomization until date of discharge (cut-off period 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Website of the Spanish Medicines Agency where the clinical trial is registered in clinical trial information system (CTIS)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide 20 Milligrams in people with Acute Heart Failure and Congestive Heart Failure, run by Instituto de Investigación Sanitaria Aragón at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant reduction in congestion (ADVOR scale) (time frame: After the first 72 hours of endovenous loop diuretic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.