Acute Decompensated Heart FailureNCT05240651
Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
An observational study of Acute Decompensated Heart Failure, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 1 Jul 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, At Discharge (up to 1 week)
Secondary outcomes (10)
Change in Stroke Volume Index (SVI) before 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.
Measured: Baseline, At Discharge (up to 1 week)
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.
Measured: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Output (CO) before passive leg raise (PLR)
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.
Measured: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Output (CO) after passive leg raise (PLR)
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.
Measured: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Index (CI) before passive leg raise (PLR)
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.
Measured: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Index (CI) after passive leg raise (PLR)
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.
Measured: Baseline, At Discharge (up to 1 week)
Change in heart rate before passive leg raise (PLR)
Measured: Baseline, At Discharge (up to 1 week)
Change in heart rate after passive leg raise (PLR)
Measured: Baseline, At Discharge (up to 1 week)
Change in Mean arterial pressure before passive leg raise (PLR)
Measured: Baseline, At Discharge (up to 1 week)
Change in Mean arterial pressure after passive leg raise (PLR)
Measured: Baseline, At Discharge (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start30 Aug 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Study temporarily paused.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Alviar, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240651
- Sponsor's protocol ID
- 20-02048
- Status last verified
- May 2026
- First submitted
- 13 Feb 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT05240651
- Acronym / sponsor ID
- 20-02048
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study temporarily paused.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
Time frame: 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.
10 secondary outcomes
Change in Stroke Volume Index (SVI) before passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Output (CO) before passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Output (CO) after passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Index (CI) before passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in estimated Cardiac Index (CI) after passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in heart rate before passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in heart rate after passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in Mean arterial pressure before passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Change in Mean arterial pressure after passive leg raise (PLR)
Time frame: Baseline, At Discharge (up to 1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Alviar, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR) (time frame: Baseline, At Discharge (up to 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.