The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in… (NCT07008365) | Clinical Trial Compass
RecruitingPhase 3
The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
Spain168 participantsStarted 2025-03-10
Plain-language 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). 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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).
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Significant reduction in congestion (ADVOR scale)
Timeframe: After the first 72 hours of endovenous loop diuretic treatment
Trial details
NCT IDNCT07008365
SponsorInstituto de Investigación Sanitaria Aragón