A Phase 3 interventional study of Furosemide 20 Milligrams in Acute Heart Failure, Congestive Heart Failure and Intraabdominal Hypertension, sponsored by Instituto de Investigación Sanitaria Aragón. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Instituto de Investigación Sanitaria Aragón · Phase 3, Interventional, and Treatment
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.
85 studies on the registry are indexed under Cardio-Renal Syndrome; 20 are open to participants now.
This study's planned enrollment of 168 is above the median of 50 across 55 interventional studies indexed under Cardio-Renal Syndrome.
Browse Cardio-Renal Syndrome studies →Instituto de Investigación Sanitaria Aragón is the lead sponsor of 32 studies on the registry; 12 are open to participants now.
Compared within Cardio-Renal Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Failure. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Loop diuretics (furosemide) will be administered intravenously according to stantard of care (Latest European heart failure guidelines)
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
Drug: Furosemide 20 Milligrams
Decongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound
Also known as: furosemide 500 milligrams, hydrochlorothiazide 25 milligrams
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
Time frame: After the first 72 hours of endovenous loop diuretic treatment
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
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)
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
Time frame: 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).
Time frame: 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.
Time frame: 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.
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
Differences in cardiovascular death incidence
Time frame: 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
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
Differences in length of stay between both arms
Time frame: From date of randomization until date of discharge (cut-off period 4 weeks)
Plan to share: Undecided
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Instituto de Investigación Sanitaria Aragón