Ultra-sound Assisted Management of Heart Failure (USA-HF)
Primary Purpose
Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand Held Ultrasound
Sponsored by

About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- New admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, CXR showing pulmonary vascular congestion/pulmonary edema, elevated NTproBNP, dyspnea Not secondary to infectious process (pneumonia).
- Heart failure NYHA class III, IV
- Age>=18 years old
Exclusion Criteria:
- End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
- end stage Heart failure on chronic inotrope (example Milrinone)
- Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
- morbid obesity BMI > 40
- incarcerated patients (prison) TDC.
- pregnant patients
- Patients with dyspnea not mainly due to heart failure, ESRD patients, intubated patients
- Aged less than 18 years.
Sites / Locations
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ultra Sound Guided Therapy Group
Conventional Therapy Group
Arm Description
Hand carried ultrasound will be used in this group to measure IVCd, collapsibility along with internal jugular vein collapsibility. The results of the ultrasound will be unblinded to the treating team.
Conventional therapy will occur the use of hand carried ultrasound. The results will be blinded to the treating team. The managing team will analyze the data at the end of the study.
Outcomes
Primary Outcome Measures
length of hospital stay (days)
number of days from admission to discharge
Secondary Outcome Measures
Number of participants readmitted for heart failure with 30 days of discharge, and percentage of participant out of all participants in each group readmitted in each group within 30 days
Follow up telephone call after discharge
number of participant readmitted for any reason within 30 days of discharge, and percentage of participant ( out of all participant in each group) readmitted in each group within 30 days of discharge.
assessment of readmission to hospital
percent change in GFR
amount of change in GFR
hospitalization Cost
hospitalization cost measured for all hospitalization stay from admission to discharge for each participant
Time to readmission
time between original hospitalization and readmission
Number of right heart catheterization in each group and percentage of right heart catheterization in each group
document what procedures were done
Full Information
NCT ID
NCT04376424
First Posted
April 14, 2020
Last Updated
November 23, 2021
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT04376424
Brief Title
Ultra-sound Assisted Management of Heart Failure
Acronym
USA-HF
Official Title
Hand Carried Ultra-Sound Assisted Medical Management of Acute Decompensated Heart Failure. A Randomized Controlled Trial (USA-HF)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No data has been collected, no subjects enrolled
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation.
Detailed Description
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. The use of hand carried ultrasound is expected to reduce hospital Length of stay, heart failure re-admission rates, emergency room visits and in hospital complications such as renal failure. The hypothesis tested is as follows:
Null: The use of hand carried ultrasound in the management of heart failure patients did not change outcome.
Alternative: The use of hand carried ultrasound in the management of heart failure patients did change outcome.
The study endpoints are as follows:
A primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay.
The secondary endpoint will be 30 days re-admission following heart failure hospitalization, emergency room visits and in hospital complications such as renal failure.
This is a randomized controlled un-blinded study that poses very minimal risk because patients will only undergo an ultrasound measurement of Inferior vein cava (IVC) and internal jugular vein diameter and compressibility. Also, the society will benefit greatly with the prospect of reducing hospitalization and medical complications, optimizing healthcare delivery to heart failure patients, and reducing hospitalization cost. The results of this study/study procedure will only direct medical therapy that heart failure patients usually receive through routine care such as dose and frequency of diuresis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultra Sound Guided Therapy Group
Arm Type
Experimental
Arm Description
Hand carried ultrasound will be used in this group to measure IVCd, collapsibility along with internal jugular vein collapsibility. The results of the ultrasound will be unblinded to the treating team.
Arm Title
Conventional Therapy Group
Arm Type
No Intervention
Arm Description
Conventional therapy will occur the use of hand carried ultrasound. The results will be blinded to the treating team. The managing team will analyze the data at the end of the study.
Intervention Type
Diagnostic Test
Intervention Name(s)
Hand Held Ultrasound
Intervention Description
Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
Primary Outcome Measure Information:
Title
length of hospital stay (days)
Description
number of days from admission to discharge
Time Frame
Immediately after discharge
Secondary Outcome Measure Information:
Title
Number of participants readmitted for heart failure with 30 days of discharge, and percentage of participant out of all participants in each group readmitted in each group within 30 days
Description
Follow up telephone call after discharge
Time Frame
One month after discharge
Title
number of participant readmitted for any reason within 30 days of discharge, and percentage of participant ( out of all participant in each group) readmitted in each group within 30 days of discharge.
Description
assessment of readmission to hospital
Time Frame
One month after original discharge
Title
percent change in GFR
Description
amount of change in GFR
Time Frame
One month after original discharge
Title
hospitalization Cost
Description
hospitalization cost measured for all hospitalization stay from admission to discharge for each participant
Time Frame
immediately after discharge of hospitalization
Title
Time to readmission
Description
time between original hospitalization and readmission
Time Frame
assessed within 4 weeks from index admission (i.e. thirty days readmission)
Title
Number of right heart catheterization in each group and percentage of right heart catheterization in each group
Description
document what procedures were done
Time Frame
One month after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
New admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, CXR showing pulmonary vascular congestion/pulmonary edema, elevated NTproBNP, dyspnea Not secondary to infectious process (pneumonia).
Heart failure NYHA class III, IV
Age>=18 years old
Exclusion Criteria:
End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
end stage Heart failure on chronic inotrope (example Milrinone)
Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
morbid obesity BMI > 40
incarcerated patients (prison) TDC.
pregnant patients
Patients with dyspnea not mainly due to heart failure, ESRD patients, intubated patients
Aged less than 18 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wissam Khalife, MD
Organizational Affiliation
University of Texas Medical Branch Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultra-sound Assisted Management of Heart Failure
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