Status:
RECRUITING
POCUS-Guided Diuresis for Decompensated Heart Failure
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
American Heart Association
Conditions:
Heart Decompensation, Acute
Acute Kidney Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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 sever...
Detailed Description
Heart failure is a major cause of hospitalization in the United States, affecting over 5 million adults, with 30-day readmission rates as high as 22%. Hospitalizations account for the majority of acut...
Eligibility Criteria
Inclusion
- List the inclusion criteria:
- Age: Patients must be 18 years or older.
- Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF).
- Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics.
- 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:
- Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments.
- 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.
- Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded.
- End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study.
- Advanced Cancer: Patients with metastatic cancer will be excluded.
- Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded.
- End stage chronic kidney disease
- Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible.
- 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.
Exclusion
Key Trial Info
Start Date :
June 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT06921603
Start Date
June 29 2025
End Date
December 1 2026
Last Update
August 11 2025
Active Locations (3)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
3
UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232