Recruitment

Recruitment Status
Terminated
Estimated Enrollment
138

Inclusion Criterias

NYHA class II-IV (ambulatory only)
history of hospitalization for heart failure within the last year (ambulatory only)
Patients with a diagnosis of congestive heart failure
...
NYHA class II-IV (ambulatory only)
history of hospitalization for heart failure within the last year (ambulatory only)
Patients with a diagnosis of congestive heart failure
admission to heart failure service (inpatient arm only)
age >18 years old
left ventricular systolic dysfunction with ejection fraction (EF) < 50%

Exclusion Criterias

body mass index higher than 35
a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
acute coronary syndromes within the previous 10 days
...
body mass index higher than 35
a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
acute coronary syndromes within the previous 10 days
serum creatinine level higher than 2.49 mg/dL
participating in another study
a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only)
no follow-up possible
revascularization within the previous month
unable to give informed consent
non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only)
valvular disease requiring surgery
Patients with dyspnea not mainly due to heart failure

Summary

Conditions
Heart Failure
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 rea...

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.

Inclusion Criterias

NYHA class II-IV (ambulatory only)
history of hospitalization for heart failure within the last year (ambulatory only)
Patients with a diagnosis of congestive heart failure
...
NYHA class II-IV (ambulatory only)
history of hospitalization for heart failure within the last year (ambulatory only)
Patients with a diagnosis of congestive heart failure
admission to heart failure service (inpatient arm only)
age >18 years old
left ventricular systolic dysfunction with ejection fraction (EF) < 50%

Exclusion Criterias

body mass index higher than 35
a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
acute coronary syndromes within the previous 10 days
...
body mass index higher than 35
a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
acute coronary syndromes within the previous 10 days
serum creatinine level higher than 2.49 mg/dL
participating in another study
a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only)
no follow-up possible
revascularization within the previous month
unable to give informed consent
non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only)
valvular disease requiring surgery
Patients with dyspnea not mainly due to heart failure

Locations

New York, New York, 10029
New York, New York, 10029

Tracking Information

NCT #
NCT01962688
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jagat Narula, MD, PhD Icahn School of Medicine at Mount Sinai
  • Jagat Narula, MD, PhD Icahn School of Medicine at Mount Sinai