Actively Recruiting
The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
Led by Instituto de Investigación Sanitaria Aragón · Updated on 2025-06-06
168
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to treat patients admitted with acute heart failure (AHF) who experience systemic venous congestion. This randomized, multicenter clinical trial aims to compare the usual care of intravenous loop diuretics with a strategy guided by intra-abdominal pressure (IAP) measurements and clinical ultrasound. The goal is to determine if this guided approach can better optimize diuretic treatment and improve outcomes for patients with persistent congestion symptoms after hospital admission. Participants will be randomly assigned to one of two groups: standard diuretic treatment based on usual clinical practice, or treatment adjusted according to IAP levels and ultrasound findings of the inferior vena cava and portal Doppler. The study involves administering intravenous loop diuretics such as furosemide, with dosing tailored to IAP measurements. For example, patients with normal IAP receive a dose twice their previous oral dose, while those with higher IAP may receive combinations including hydrochlorothiazide or continuous infusions. This treatment strategy is maintained during the first 72 hours of hospital admission. During the study, participants will undergo detailed assessments of congestion and diuretic response, including clinical evaluations, ultrasound imaging, and measurement of urine output. Researchers will monitor outcomes like reduction in congestion using the ADVOR scale and lung ultrasound, total diuresis, diuretic dose, hospital length of stay, and cardiovascular events up to one year post-discharge. The study includes careful safety monitoring and follow-up visits, with total participation spanning hospital stay and post-discharge periods.
CONDITIONS
Brief Title
The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women over 18 years old
- Diagnosed with heart failure based on the latest 2022 guidelines
- NT-proBNP greater than 1000 pg/mL or BNP greater than 250 pg/mL
- Able to have a urinary catheter placed for intra-abdominal pressure measurement
- Presence of clinical signs of congestion such as edema, ascites, or pleural effusion
- Signed informed consent to participate
You will not qualify if you...
- Hospital stay in Internal Medicine department longer than 24 hours before enrollment
- No significant clinical congestion (ADVOR score of 0 at randomization)
- Refusal to participate in the trial
- Inability or contraindication to place a urinary catheter
- Systolic blood pressure below 100 mmHg at admission
- Heart rate above 170 beats per minute at admission
- Presence of cardiogenic shock or acute myocardial ischemia
- Receiving renal replacement therapy or history of kidney transplant
- Hemoglobin level below 9 g/dL
- Pregnancy or breastfeeding
- Allergy to hydrochlorothiazide or furosemide
- Admission from Intensive Care Unit
- Recent cardiac surgery within the last year or heart transplant recipient
- Need for inotropic support to maintain heart or kidney function
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours of endovenous loop diuretic treatment
Participants receive intravenous diuretic treatment (furosemide +/- hydrochlorothiazide) guided either by standard of care or adjusted based on intra-abdominal pressure and/or point of care ultrasound to manage heart failure congestion.
Daily visits during treatment at the Internal Medicine ward
Duration - Up to 90 days post-hospitalization
Participants are monitored for heart failure worsening, cardiovascular events, and treatment outcomes up to 90 days post-hospitalization.
Visits at 30 days and 90 days post-discharge
Trial Site Locations
Total: 2 locations
1
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50008
Actively Recruiting
2
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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