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

June 4, 2018 updated by: Jagat Narula, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Handheld ultrasound - inpatient
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy
Device: Handheld ultrasound
Handheld ultrasound determination of IVC diameter
Other Names:
  • VSCAN
  • Handheld Ultrasound IVC Diameter Guided Diuretic Therapy
Sham Comparator: Sham ultrasound - inpatient
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
sham ultrasound to facilitate blinding
Other Names:
  • Conventional Symptom Guided Diuretic Therapy
Experimental: Handheld ultrasound - ambulatory
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
Handheld ultrasound determination of IVC diameter
Other Names:
  • VSCAN
  • Handheld Ultrasound IVC Diameter Guided Diuretic Therapy
Sham Comparator: Sham ultrasound - ambulatory
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
sham ultrasound to facilitate blinding
Other Names:
  • Conventional Symptom Guided Diuretic Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Hospitalized for Cardiovascular Reasons
Time Frame: up to 6 months
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
Time Frame: up to 6 months
hospitalization information will be recorded throughout the length of the study for the inpatient arms
up to 6 months
Diuretic Change Post-visit
Time Frame: 6 months followup
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
Time Frame: 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.
6 months
Change in Health Related Quality of Life
Time Frame: 1 month and 6 months
Change in Health related quality of life at 6 months as compared to at 1 month
1 month and 6 months
Length of Stay
Time Frame: up to 6 months
length of stay in the hospital for inpatient arms only
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Jagat Narula, MD, PhD, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 13-0324
  • IF1486768 (Other Identifier: Mount Sinai)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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