NCT07008365RecruitingPhase 3
The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 8 Aug 2024
- Start date
- 10 Mar 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT07008365
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 168
- From 10 Mar 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
- Kidney transplant recipients.
Other illness
- Heart rate at admission \> 170 beats per minute (bpm).
- Acute myocardial ischemia.
- History of hypersensitivity to hydrochlorothiazide or furosemide.
- 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.
Lab values
- Serum hemoglobin \< 9 g/dL.
Other
- 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.
- Cardiogenic shock.
- Pregnancy or breastfeeding.
- Patients admitted from the Intensive Care Unit.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.