NCT07008365 The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
| NCT ID | NCT07008365 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Instituto de Investigación Sanitaria Aragón |
| Condition | Acute Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 168 participants in total. It began in 2025-03-10 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07008365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Acute Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07008365 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 168 participants.
Is NCT07008365 currently recruiting?
Yes, NCT07008365 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto de Investigación Sanitaria Aragón to inquire about joining.
Where is the NCT07008365 trial being conducted?
This trial is being conducted at Zaragoza, Spain, Zaragoza, Spain.
Who is sponsoring the NCT07008365 clinical trial?
NCT07008365 is sponsored by Instituto de Investigación Sanitaria Aragón. The trial plans to enroll 168 participants.
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