Heart Failure
Conditions
Keywords
Heart Failure, Handheld ultrasound, Inferior Vena Cava
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.
Interventions
DEVICEHandheld ultrasound
Handheld ultrasound determination of IVC diameter
DEVICESham ultrasound
sham ultrasound to facilitate blinding
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Heart Failure patients presented at outpatient clinics were prospectively recruited.
Participants by arm
| Arm | Count |
|---|---|
| Handheld Ultrasound Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status. | 19 |
| Clinical Assessment Only Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status. | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | Handheld Ultrasound | Clinical Assessment Only | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 16.7 | 61.5 years STANDARD_DEVIATION 11.7 | 61.2 years STANDARD_DEVIATION 14.3 |
| Body Mass Index (BMI) | 26.3 kg/m^2 STANDARD_DEVIATION 4.7 | 26.4 kg/m^2 STANDARD_DEVIATION 5.5 | 26.4 kg/m^2 STANDARD_DEVIATION 4.9 |
| Diuretic use no | 1 participants | 3 participants | 4 participants |
| Diuretic use yes | 18 participants | 15 participants | 33 participants |
| Ejection Fraction | 24.8 percent STANDARD_DEVIATION 8.4 | 24.2 percent STANDARD_DEVIATION 9.5 | 24.5 percent STANDARD_DEVIATION 8.8 |
| Ischemic Cardiomyopathy no | 11 participants | 7 participants | 18 participants |
| Ischemic Cardiomyopathy yes | 8 participants | 11 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 7 / 19 | 10 / 18 |
Outcome results
Primary
Diuretic Change Post-visit
Differences in Changes made in Diuretic doses after Heart failure related visit
Time frame: 6 months followup
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Handheld Ultrasound | Diuretic Change Post-visit | Increase | 10 Number of visits |
| Handheld Ultrasound | Diuretic Change Post-visit | Decrease | 6 Number of visits |
| Handheld Ultrasound | Diuretic Change Post-visit | Stay the same | 15 Number of visits |
| Clinical Assessment Only | Diuretic Change Post-visit | Increase | 7 Number of visits |
| Clinical Assessment Only | Diuretic Change Post-visit | Decrease | 4 Number of visits |
| Clinical Assessment Only | Diuretic Change Post-visit | Stay the same | 54 Number of visits |
p-value: 0.002Chi-squared
Primary
Number of Participants Hospitalized for Cardiovascular Reasons
hospitalization information will be recorded throughout the length of the study for the outpatient arms
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Handheld Ultrasound | Number of Participants Hospitalized for Cardiovascular Reasons | 4 Participants |
| Clinical Assessment Only | Number of Participants Hospitalized for Cardiovascular Reasons | 5 Participants |
Primary
Number of Participants Hospitalized for Non-cardiac Reasons
hospitalization information will be recorded throughout the length of the study for the inpatient arms
Time frame: up to 6 months
Population: All patients in clinical assessment only group were hospitalized for non-cardiac reasons
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Handheld Ultrasound | Number of Participants Hospitalized for Non-cardiac Reasons | 6 Participants |
| Clinical Assessment Only | Number of Participants Hospitalized for Non-cardiac Reasons | 18 Participants |
Secondary
Change in Health Related Quality of Life
Change in Health related quality of life at 6 months as compared to at 1 month
Time frame: 1 month and 6 months
Population: Data not collected
Secondary
Length of Stay
length of stay in the hospital for inpatient arms only
Time frame: up to 6 months
Population: Data not collected
Secondary
Number of Participants in Each New York Heart Association Class
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.
Time frame: 6 months
Population: Analyzed total 96 visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Handheld Ultrasound | Number of Participants in Each New York Heart Association Class | NYHA Class I | 0 visits |
| Handheld Ultrasound | Number of Participants in Each New York Heart Association Class | NYHA Class III | 22 visits |
| Handheld Ultrasound | Number of Participants in Each New York Heart Association Class | NYHA Class II | 9 visits |
| Handheld Ultrasound | Number of Participants in Each New York Heart Association Class | NYHA Class IV | 0 visits |
| Clinical Assessment Only | Number of Participants in Each New York Heart Association Class | NYHA Class IV | 2 visits |
| Clinical Assessment Only | Number of Participants in Each New York Heart Association Class | NYHA Class I | 1 visits |
| Clinical Assessment Only | Number of Participants in Each New York Heart Association Class | NYHA Class II | 18 visits |
| Clinical Assessment Only | Number of Participants in Each New York Heart Association Class | NYHA Class III | 39 visits |