NCT06921603 POCUS-Guided Diuresis for Decompensated Heart Failure
| NCT ID | NCT06921603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Heart Decompensation, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 588 participants |
| Start Date | 2025-06-29 |
| Primary Completion | 2026-12 |
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.
This trial targets 588 participants in total. It began in 2025-06-29 with a primary completion date of 2026-12.
⚠ 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
Heart failure occurs when the heart cannot pump blood effectively, leading to fluid buildup in the body. This can cause problems such as difficulty breathing, swelling, and extreme tiredness. In severe cases, these symptoms worsen to the point where hospitalization is required. Unfortunately, many patients with severe heart failure are readmitted to the hospital within 30 days after discharge, which is both physically and emotionally challenging for patients and places a significant financial burden on individuals and the healthcare system. Although symptoms such as difficulty breathing and swelling may improve during the hospital stay, some patients are discharged with excess fluid remaining in their bodies. This retained fluid often causes symptoms to worsen, leading to subsequent hospital readmissions. Inadequate management of fluid levels can also harm the kidneys, further complicating the patient's condition. This study aims to improve care for heart failure patients by utilizing a simple, non-invasive tool to assess fluid levels more accurately at the bedside. The tool measures the size of a large blood vessel in the neck, providing key information about the pressure inside the heart. This information enables clinicians to determine the appropriate amount of medication needed to remove just the right amount of fluid. Properly managing fluid levels can help prevent kidney damage and improve overall patient outcomes. The primary goal of this study is to evaluate whether this tool can reduce the number of patients readmitted to the hospital within 30 days of discharge. A secondary goal is to determine whether the tool can help protect kidney function by allowing for better fluid management. If successful, this approach has the potential to help heart failure patients stay healthier, reduce hospital visits, and lower healthcare costs.
Eligibility Criteria
List the inclusion criteria: 1. Age: Patients must be 18 years or older. 2. Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF). 3. Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics. 4. POCUS Measurement: Must have an abnormal right internal jugular vein (RIJV) distensibility index (DI) of \<66% on point-of-care ultrasound (POCUS) at the time of admission. These criteria ensure that participants are appropriately selected for the study and are likely to benefit from POCUS-guided diuretic management. List the exclusion criteria: 1. Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments. 2. Anatomical Incompatibilities: Excludes patients with RIJV or superior vena cava thrombus, congenital heart disease, or severe tricuspid regurgitation, as these conditions may impair accurate POCUS measurements. 3. Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded. 4. End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study. 5. Advanced Cancer: Patients with metastatic cancer will be excluded. 6. Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded. 7. End stage chronic kidney disease 8. Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible. 9. Inotropic Support: Patients requiring inotropic support at the time of enrollment will be excluded, as they represent a more severe heart failure profile that may not be suitable for this trial.
Contact & Investigator
John J Pacella, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh Medical Center (UPMC)
Frequently Asked Questions
Who can join the NCT06921603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Decompensation, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921603 currently recruiting?
Yes, NCT06921603 is actively recruiting participants. Contact the research team at pacellajj@upmc.edu for enrollment information.
Where is the NCT06921603 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Pittsburgh, United States, Pittsburgh, United States, Pittsburgh, United States and 1 additional location.
Who is sponsoring the NCT06921603 clinical trial?
NCT06921603 is sponsored by University of Pittsburgh. The principal investigator is John J Pacella, MD at University of Pittsburgh Medical Center (UPMC). The trial plans to enroll 588 participants.