Ultra-sound Assisted Management of Heart Failure (USA-HF)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Hand Held Ultrasound

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:

1. A primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay.
2. 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. Heart failure NYHA class III, IV
3. Age>=18 years old

Exclusion Criteria:

1. End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
2. end stage Heart failure on chronic inotrope (example Milrinone)
3. Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
4. morbid obesity BMI > 40
5. incarcerated patients (prison) TDC.
6. pregnant patients
7. Patients with dyspnea not mainly due to heart failure, ESRD patients, intubated patients
8. Aged less than 18 years.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultra Sound Guided Therapy Group; 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; Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
No Intervention: Conventional Therapy Group; 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?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Wissam Khalife, MD, University of Texas Medical Branch Galveston

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 19-0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes