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
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 of age.
- Diagnosis of heart failure based on the latest 2022 guidelines.
- NT-proBNP greater than 1000 pg/mL or BNP greater than 250 pg/mL.
- Placement of a urinary catheter to measure intra-abdominal pressure.
- Presence of one or more clinical signs of congestion such as edema, ascites, or pleural effusion.
- Signed informed consent to participate in the study.
You will not qualify if you...
- Hospital stay in the Internal Medicine department longer than 24 hours.
- No sufficient 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 less than 100 mmHg at admission.
- Heart rate greater than 170 beats per minute at admission.
- Cardiogenic shock.
- Acute myocardial ischemia.
- Receiving renal replacement therapy like ultrafiltration or peritoneal dialysis.
- Kidney transplant recipients.
- Serum hemoglobin less than 9 g/dL.
- Pregnancy or breastfeeding.
- History of hypersensitivity to hydrochlorothiazide or furosemide.
- Admission from the Intensive Care Unit.
- Recent cardiac surgery within the last year or heart transplant recipients.
- Need for inotropic support to maintain adequate cardiac or renal output.
AI-Screening
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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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