Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Objectives The objective of the study is to determine whether a simple one step protocol of increasing diuretics to guide a 50% reduction of IVC diameter from baseline measurements results in reduction in hospitalization rates as compared to those seen in therapy determined on the basis of conventional clinical evaluation by a CHF specialist. Background Congestive heart failure (CHF) remains a leading cause of death in industrialized countries. Despite advances in medical treatment, an estimated 250,000-300,000 CHF patients are hospitalized in the United States each year for symptoms caused by low cardiac output (CO). Although the events that cause acute decompensation are multifactorial, the common pathway associated with decreased ventricular function are autonomic dysfunction and fluid retention. It has been previously suggested that an estimated 50%-66% of CHF hospitalizations may be preventable with improved monitoring of fluid volume status. The size and shape of the inferior vena cava (IVC) is correlated to the central venous pressure and circulating blood volume. Therefore evaluation of the IVC provides an instantaneous non-invasive measure of volume status.

Official Title
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A Randomized Study of Pocket Ultrasound Derived IVC Diameter for Guided Management of Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Handheld ultrasound
* Device: Sham ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of congestive heart failure NYHA class II-IV (ambulatory only) left ventricular systolic dysfunction with ejection fraction (EF) < 50% history of hospitalization for heart failure within the last year (ambulatory only) age >18 years old admission to heart failure service (inpatient arm only) Exclusion Criteria: Patients with dyspnea not mainly due to heart failure valvular disease requiring surgery acute coronary syndromes within the previous 10 days revascularization within the previous month body mass index higher than 35 serum creatinine level higher than 2.49 mg/dL a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only) a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only) non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only) unable to give informed consent no follow-up possible participating in another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handheld ultrasound - inpatient<br>Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy | Device: Handheld ultrasound<br>* Handheld ultrasound determination of IVC diameter<br>* Other names: Handheld Ultrasound IVC Diameter Guided Diuretic Therapy;|
| Sham Comparator: Sham ultrasound - inpatient<br>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<br>* sham ultrasound to facilitate blinding<br>* Other names: Conventional Symptom Guided Diuretic Therapy;|
| Experimental: Handheld ultrasound - ambulatory<br>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<br>* Handheld ultrasound determination of IVC diameter<br>* Other names: Handheld Ultrasound IVC Diameter Guided Diuretic Therapy;|
| Sham Comparator: Sham ultrasound - ambulatory<br>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<br>* sham ultrasound to facilitate blinding<br>* Other names: Conventional Symptom Guided Diuretic Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Hospitalized for Cardiovascular Reasons | hospitalization information will be recorded throughout the length of the study for the outpatient arms | 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 | up to 6 months | 
| Diuretic Change Post-visit | Differences in Changes made in Diuretic doses after Heart failure related visit | 6 months followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 1 month and 6 months | 
| Length of Stay | length of stay in the hospital for inpatient arms only | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Handheld ultrasound, Inferior Vena Cava