Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure

Recruiting

• Conditions: Acute Decompensated Heart Failure

• Registration Number: NCT05240651
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a prospective cohort study for 50 patients admitted to the cardiac care unit requiring clinically-indicated diuretic therapy for congestive heart failure. The purpose of this study is to assess the role of non-invasive cardiac output monitoring (NICOM) with the Starling Fluid Management System (Baxter Medical, Deerfield, IL) in determining volume status in patients with acute decompensated heart failure requiring intravenous diuretic therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-13
• Study First Submitted QC: 2022-02-13
• Study First Posted: 2022-02-15
• Study Start: 2022-08-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.

Secondary Outcome Measures

Name	Time	Method
Change in Stroke Volume Index (SVI) after passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.
Change in estimated Cardiac Output (CO) before passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CO. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CO.
Change in estimated Cardiac Output (CO) after passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CO. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CO.
Change in heart rate after passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)
Change in Stroke Volume Index (SVI) before passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.
Change in estimated Cardiac Index (CI) before passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CI.
Change in estimated Cardiac Index (CI) after passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CI.
Change in heart rate before passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)
Change in Mean arterial pressure before passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)
Change in Mean arterial pressure after passive leg raise (PLR)	Baseline, At Discharge (up to 1 week)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States