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

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.

1. 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.

2. 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.

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