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

Mount Sinai Health System

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Handheld ultrasound; Device: Sham ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01962688

IF1486768 (Other Identifier)

GCO 13-0324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

37 participants in 4 patient groups

Handheld ultrasound - inpatient

Experimental group

Description:

Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy

Treatment:

Device: Handheld ultrasound

Sham ultrasound - inpatient

Sham Comparator group

Description:

Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study. These patients receive a sham ultrasound to facilitate blinding

Treatment:

Device: Sham ultrasound

Handheld ultrasound - ambulatory

Experimental group

Description:

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.

Treatment:

Device: Handheld ultrasound

Sham ultrasound - ambulatory

Sham Comparator group

Description:

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.

Treatment:

Device: Sham ultrasound