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

Not Applicable

Terminated

Conditions: Heart Failure

Interventions: Device: Handheld ultrasound
Device: Sham ultrasound

Registration Number: NCT01962688

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 37

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handheld ultrasound - inpatient	Handheld ultrasound	Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy
Sham ultrasound - inpatient	Sham 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
Handheld ultrasound - ambulatory	Handheld 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.
Sham ultrasound - ambulatory	Sham 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Hospitalized for Cardiovascular Reasons	up to 6 months	hospitalization information will be recorded throughout the length of the study for the outpatient arms
Number of Participants Hospitalized for Non-cardiac Reasons	up to 6 months	hospitalization information will be recorded throughout the length of the study for the inpatient arms
Diuretic Change Post-visit	6 months followup	Differences in Changes made in Diuretic doses after Heart failure related visit

Secondary Outcome Measures

Name	Time	Method
Number of Participants in Each New York Heart Association Class	6 months	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.
Change in Health Related Quality of Life	1 month and 6 months	Change in Health related quality of life at 6 months as compared to at 1 month
Length of Stay	up to 6 months	length of stay in the hospital for inpatient arms only