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

NCT ID: NCT05240651

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-30

Study Completion Date

2026-07-01

Brief Summary

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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

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Conditions

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Acute Decompensated Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Alviar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carlos Alviar, MD

Role: CONTACT

212-263-6635

Other Identifiers

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20-02048

Identifier Type: -

Identifier Source: org_study_id

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