Ultra-sound Assisted Management of Heart Failure

NCT04376424 | Withdrawn FDA Device

• 1 other identifier: 19-0276
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• length of hospital stay (days)

  number of days from admission to discharge

  Immediately after discharge

Secondary Outcomes (6)

• 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

  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.

  One month after original discharge

• percent change in GFR

  One month after original discharge

• hospitalization Cost

  immediately after discharge of hospitalization

• Time to readmission

  assessed within 4 weeks from index admission (i.e. thirty days readmission)

Study Arms (2)

Ultra Sound Guided Therapy Group

EXPERIMENTAL

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

Conventional Therapy Group

NO INTERVENTION

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.

Interventions

Hand Held Ultrasound DIAGNOSTIC_TEST

Guideline directed medical therapy for heart failure with the addition of hand held ultrasound

Ultra Sound Guided Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wissam Khalife, MD

  University of Texas Medical Branch Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 6, 2020
• Study Start: November 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 17, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)