Trial Outcomes & Findings for Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment (NCT NCT01962688)
NCT ID: NCT01962688
Last Updated: 2018-06-06
Results Overview
hospitalization information will be recorded throughout the length of the study for the outpatient arms
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
up to 6 months
Results posted on
2018-06-06
Participant Flow
Heart Failure patients presented at outpatient clinics were prospectively recruited.
Participant milestones
| Measure |
Handheld Ultrasound
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment
Baseline characteristics by cohort
| Measure |
Handheld Ultrasound
n=19 Participants
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
n=18 Participants
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.3 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Ischemic Cardiomyopathy
yes
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Ischemic Cardiomyopathy
no
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Ejection Fraction
|
24.8 percent
STANDARD_DEVIATION 8.4 • n=5 Participants
|
24.2 percent
STANDARD_DEVIATION 9.5 • n=7 Participants
|
24.5 percent
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Diuretic use
yes
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Diuretic use
no
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthshospitalization information will be recorded throughout the length of the study for the outpatient arms
Outcome measures
| Measure |
Handheld Ultrasound
n=19 Participants
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
n=18 Participants
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
|---|---|---|
|
Number of Participants Hospitalized for Cardiovascular Reasons
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: All patients in clinical assessment only group were hospitalized for non-cardiac reasons
hospitalization information will be recorded throughout the length of the study for the inpatient arms
Outcome measures
| Measure |
Handheld Ultrasound
n=19 Participants
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
n=18 Participants
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
|---|---|---|
|
Number of Participants Hospitalized for Non-cardiac Reasons
|
6 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 6 months followupDifferences in Changes made in Diuretic doses after Heart failure related visit
Outcome measures
| Measure |
Handheld Ultrasound
n=31 Number of visits
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
n=65 Number of visits
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
|---|---|---|
|
Diuretic Change Post-visit
Increase
|
10 Number of visits
|
7 Number of visits
|
|
Diuretic Change Post-visit
Decrease
|
6 Number of visits
|
4 Number of visits
|
|
Diuretic Change Post-visit
Stay the same
|
15 Number of visits
|
54 Number of visits
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analyzed total 96 visits
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.
Outcome measures
| Measure |
Handheld Ultrasound
n=31 Number of Visits
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
n=65 Number of Visits
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
|---|---|---|
|
Number of Participants in Each New York Heart Association Class
NYHA Class I
|
0 visits
|
1 visits
|
|
Number of Participants in Each New York Heart Association Class
NYHA Class II
|
9 visits
|
18 visits
|
|
Number of Participants in Each New York Heart Association Class
NYHA Class III
|
22 visits
|
39 visits
|
|
Number of Participants in Each New York Heart Association Class
NYHA Class IV
|
0 visits
|
2 visits
|
SECONDARY outcome
Timeframe: 1 month and 6 monthsPopulation: Data not collected
Change in Health related quality of life at 6 months as compared to at 1 month
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Data not collected
length of stay in the hospital for inpatient arms only
Outcome measures
Outcome data not reported
Adverse Events
Handheld Ultrasound
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Assessment Only
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Handheld Ultrasound
n=19 participants at risk
Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
|
Clinical Assessment Only
n=18 participants at risk
Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
|
|---|---|---|
|
Cardiac disorders
All cause Hospitalization
|
36.8%
7/19 • Number of events 10 • up to 6 months
All Cause Mortality All Cause Hospitalization Cardiac Related Hospitalizations Non-Cardiac Related Hospitalization
|
50.0%
9/18 • Number of events 23 • up to 6 months
All Cause Mortality All Cause Hospitalization Cardiac Related Hospitalizations Non-Cardiac Related Hospitalization
|
|
Cardiac disorders
Cardiac Related Hospitalization
|
21.1%
4/19 • Number of events 4 • up to 6 months
All Cause Mortality All Cause Hospitalization Cardiac Related Hospitalizations Non-Cardiac Related Hospitalization
|
27.8%
5/18 • Number of events 5 • up to 6 months
All Cause Mortality All Cause Hospitalization Cardiac Related Hospitalizations Non-Cardiac Related Hospitalization
|
|
Cardiac disorders
Non Cardiac Hospitalization
|
15.8%
3/19 • Number of events 6 • up to 6 months
All Cause Mortality All Cause Hospitalization Cardiac Related Hospitalizations Non-Cardiac Related Hospitalization
|
22.2%
4/18 • Number of events 18 • up to 6 months
All Cause Mortality All Cause Hospitalization Cardiac Related Hospitalizations Non-Cardiac Related Hospitalization
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jagat Narula
Icahn School of Mediine at Mount Sinai
Phone: 212-241-4122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place