Ultra-sound Assisted Management of Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hand Carried Ultra-Sound Assisted Medical Management of Acute Decompensated Heart Failure. A Randomized Controlled Trial (USA-HF)

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Hand Held Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultra Sound Guided Therapy Group<br>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. | Diagnostic Test: Hand Held Ultrasound<br>* Guideline directed medical therapy for heart failure with the addition of hand held ultrasound<br>|
| No Intervention: Conventional Therapy Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay (days) | number of days from admission to discharge | Immediately after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One month 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 | One month after original discharge | 
| percent change in GFR | amount of change in GFR | One month after original discharge | 
| hospitalization Cost | hospitalization cost measured for all hospitalization stay from admission to discharge for each participant | immediately after discharge of hospitalization | 
| Time to readmission | time between original hospitalization and readmission | assessed within 4 weeks from index admission (i.e. thirty days readmission) | 
| Number of right heart catheterization in each group and percentage of right heart catheterization in each group | document what procedures were done | One month after admission |