Ultra-sound Assisted Management of Heart Failure

Heart Failure Clinical Trial

— USA-HF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04376424
• Other study ID #: 19-0276
• Status: Withdrawn
• Phase: N/A
• Start date: November 2021
• Est. completion date: November 17, 2021

Study information

• Verified date: July 2021
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 17, 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Hand Held Ultrasound
Guideline directed medical therapy for heart failure with the addition of hand held ultrasound

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay (days)	number of days from admission to discharge	Immediately after discharge
Secondary	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
Secondary	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
Secondary	percent change in GFR	amount of change in GFR	One month after original discharge
Secondary	hospitalization Cost	hospitalization cost measured for all hospitalization stay from admission to discharge for each participant	immediately after discharge of hospitalization
Secondary	Time to readmission	time between original hospitalization and readmission	assessed within 4 weeks from index admission (i.e. thirty days readmission)
Secondary	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