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

NCT05240651 | Suspended

• 1 other identifier: 20-02048
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)

  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.

  Baseline, At Discharge (up to 1 week)

Secondary Outcomes (10)

• Change in Stroke Volume Index (SVI) before passive leg raise (PLR)

  Baseline, At Discharge (up to 1 week)

• Change in Stroke Volume Index (SVI) after passive leg raise (PLR)

  Baseline, At Discharge (up to 1 week)

• Change in estimated Cardiac Output (CO) before passive leg raise (PLR)

  Baseline, At Discharge (up to 1 week)

• Change in estimated Cardiac Output (CO) after passive leg raise (PLR)

  Baseline, At Discharge (up to 1 week)

• Change in estimated Cardiac Index (CI) before passive leg raise (PLR)

  Baseline, At Discharge (up to 1 week)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Adults age \> 18 * Decompensated heart failure requiring clinically-indicated intravenous (IV) diuresis * Admission to the cardiac care unit (CCU) or the step down unit (SDU) * Ability to perform a passive leg raise (PLR)

You may qualify if:

• Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis
• Admission to coronary/cardiac intensive care unit or cardiac step down unit
• Able to provide written informed consent
• Anticipated need for IV diuretics \> 24 hrs

You may not qualify if:

• Prisoner, pregnancy or post-partum stage, or age \< 18 years
• Known allergy to sensory material or gel
• End stage renal disease or need for CRRT
• Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation)
• Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator
• Inability to provide informed consent

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Carlos Alviar, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: February 15, 2022
• Study Start: August 30, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to carlos.alviar@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)