An interventional study of Handheld ultrasound and Sham ultrasound in Heart Failure, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Supportive care
The purpose of this study is to see if using a portable handheld ultrasound to guide diuretic therapy for heart failure patients will prevent hospital readmissions. This study will use a handheld ultrasound called a Vscan to look at a large vessel in the body called the Inferior Vena Cava (a vein leading to your heart) . The study aims to see whether changing diuretic therapy based on the size of this vessel will result in the less hospitalizations for heart failure patients as compared to just symptom guided therapy. This study is composed of two independent non-interacting trials-one in the outpatient setting and one in the inpatient setting.
The purpose of this research study is to investigate the use of pocket ultrasound device, called Vscan, in guiding diuretic therapy in ambulatory and inpatient Congestive Heart Failure (CHF) patients. Specifically, Vscan will be used to monitor Inferior Vena Cava (IVC) diameters with the goal of reaching a 50% reduction in IVC when compared to baseline measurements. We hypothesize that compared to the conventional clinical assessment Guided Diuretic Therapy, this new proposed Vscan guided therapy will result in reduction in hospitalization rates. This study is composed of two independent non-interacting randomized single blinded trials-one in the outpatient setting and one in the inpatient setting. 138 total patients and 300 patients will be recruited to the ambulatory trial and inpatient trial respectively.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 37 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy
Device: Handheld ultrasound
Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study. These patients receive a sham ultrasound to facilitate blinding
Device: Sham ultrasound
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy in the ambulatory setting during normal clinic visits.
Device: Handheld ultrasound
Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study. These patients receive a sham ultrasound to facilitate blinding in the ambulatory setting during normal clinic visits.
Device: Sham ultrasound
Handheld ultrasound determination of IVC diameter
Also known as: VSCAN, Handheld Ultrasound IVC Diameter Guided Diuretic Therapy
sham ultrasound to facilitate blinding
Also known as: Conventional Symptom Guided Diuretic Therapy
Number of Participants Hospitalized for Cardiovascular Reasons
hospitalization information will be recorded throughout the length of the study for the outpatient arms
Time frame: up to 6 months
Number of Participants Hospitalized for Non-cardiac Reasons
hospitalization information will be recorded throughout the length of the study for the inpatient arms
Time frame: up to 6 months
Diuretic Change Post-visit
Differences in Changes made in Diuretic doses after Heart failure related visit
Time frame: 6 months followup
Number of Participants in Each New York Heart Association Class
New York Heart Association (NYHA) Classification Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time frame: 6 months
Change in Health Related Quality of Life
Change in Health related quality of life at 6 months as compared to at 1 month
Time frame: 1 month and 6 months
Length of Stay
length of stay in the hospital for inpatient arms only
Time frame: up to 6 months
Heart Failure patients presented at outpatient clinics were prospectively recruited.
| Milestone | Handheld Ultrasound | Clinical Assessment Only |
|---|---|---|
| Started | 19 | 18 |
| Completed | 19 | 18 |
| Not completed | 0 | 0 |
hospitalization information will be recorded throughout the length of the study for the outpatient arms
| Participants | Handheld Ultrasound | Clinical Assessment Only |
|---|---|---|
| Number of Participants Hospitalized for Cardiovascular Reasons | 4 | 5 |
hospitalization information will be recorded throughout the length of the study for the inpatient arms
| Participants | Handheld Ultrasound | Clinical Assessment Only |
|---|---|---|
| Number of Participants Hospitalized for Non-cardiac Reasons | 6 | 18 |
Differences in Changes made in Diuretic doses after Heart failure related visit
| Number of visits | Handheld Ultrasound | Clinical Assessment Only |
|---|---|---|
| Increase | 10 | 7 |
| Decrease | 6 | 4 |
| Stay the same | 15 | 54 |
New York Heart Association (NYHA) Classification Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
| visits | Handheld Ultrasound | Clinical Assessment Only |
|---|---|---|
| NYHA Class I | 0 | 1 |
| NYHA Class II | 9 | 18 |
| NYHA Class III | 22 | 39 |
| NYHA Class IV | 0 | 2 |
Change in Health related quality of life at 6 months as compared to at 1 month
No measurements were reported for this outcome.
length of stay in the hospital for inpatient arms only
No measurements were reported for this outcome.
Collected over up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Handheld Ultrasound | 0/19 (0%) | 7/19 (36.8%) | 0/19 (0%) |
| Clinical Assessment Only | 0/18 (0%) | 10/18 (55.6%) | 0/18 (0%) |
| Event | Handheld Ultrasound | Clinical Assessment Only |
|---|---|---|
| All cause HospitalizationCardiac disorders | 7/19 | 9/18 |
| Cardiac Related HospitalizationCardiac disorders | 4/19 | 5/18 |
| Non Cardiac HospitalizationCardiac disorders | 3/19 | 4/18 |
| Age, Continuous(years) | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| Mean | 60.9 ± 16.7 | 61.5 ± 11.7 | 61.2 ± 14.3 |
| Sex: Female, Male(Participants) | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 13 | 13 | 26 |
| Body Mass Index (BMI)(kg/m^2) | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| Mean | 26.3 ± 4.7 | 26.4 ± 5.5 | 26.4 ± 4.9 |
| Ischemic Cardiomyopathy(participants) | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| yes | 8 | 11 | 19 |
| no | 11 | 7 | 18 |
| Ejection Fraction(percent) | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| Mean | 24.8 ± 8.4 | 24.2 ± 9.5 | 24.5 ± 8.8 |
| Diuretic use(participants) | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| yes | 18 | 15 | 33 |
| no | 1 | 3 | 4 |
Plan to share: No
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai