NCT04376424

Ultra-sound Assisted Management of Heart Failure

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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: 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hand Held Ultrasound	Guideline directed medical therapy for heart failure with the addition of hand held ultrasound

Timeline

• Start date: 2021-11-01
• Primary completion: 2021-11-01
• Completion: 2021-11-17
• First posted: 2020-05-06
• Last updated: 2021-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study