Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure (NCT05240651) | Clinical Trial Compass
SuspendedNot Applicable
Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
Stopped: Study temporarily paused.
United States50 participantsStarted 2022-08-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Prisoner, pregnancy or post-partum stage, or age \< 18 years
. Known allergy to sensory material or gel
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently listed as suspended — do you know why enrollment was paused, and does that affect whether this research might ever be relevant to my care?
2The study measures something called Stroke Volume Index using a passive leg raise test — can you explain what that tells you about my heart function during a decompensation episode, and how that information might change how you treat me?
3Since this trial is listed as Phase NA, which I understand often means it's more of an observational or measurement study rather than a treatment trial, does that mean there's no experimental therapy involved, and what would actually be different about my care if I were enrolled?
4Given that this study focuses on patients with acute decompensated heart failure receiving diuresis, is the passive leg raise test something you already use or could use in my treatment right now, outside of a trial?
5Are there other active studies or standard treatment protocols for acute decompensated heart failure that might be a better fit for me while this trial is suspended?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
. 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