Assessing heart function changes after diuretic treatment in heart failure patients
Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
This study is testing if a new way to monitor heart function can help doctors better manage fluid levels in patients with heart failure who need diuretics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05240651 on ClinicalTrials.gov |
What this trial studies
This observational study involves 50 patients admitted to the cardiac care unit who require diuretic therapy for acute decompensated heart failure. It aims to evaluate the effectiveness of non-invasive cardiac output monitoring using the Starling Fluid Management System to assess volume status in these patients. Participants will be monitored for changes in stroke volume index following diuresis, providing insights into fluid management in heart failure treatment. The study focuses on patients who are expected to need intravenous diuretics for more than 24 hours.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with acute decompensated heart failure requiring intravenous diuretics and admitted to a cardiac care unit.
Not a fit: Patients who are pregnant, under 18, or have end-stage renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of fluid status in patients with acute decompensated heart failure, leading to better treatment outcomes.
How similar studies have performed: Similar studies using non-invasive monitoring techniques have shown promise in managing heart failure, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis 2. Admission to coronary/cardiac intensive care unit or cardiac step down unit 3. Able to provide written informed consent 4. Anticipated need for IV diuretics \> 24 hrs Exclusion Criteria: 1. Prisoner, pregnancy or post-partum stage, or age \< 18 years 2. Known allergy to sensory material or gel 3. End stage renal disease or need for CRRT 4. Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation) 5. Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator 6. Inability to provide informed consent
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Carlos Alviar, MD — NYU Langone Health
- Study coordinator: Carlos Alviar, MD
- Email: carlos.alviar@nyulangone.org
- Phone: 212-263-6635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.