USA-HF: Ultra-sound Assisted Management of Heart Failure

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04376424
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Hand Held Ultrasound
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hand Carried Ultra-Sound Assisted Medical Management of Acute Decompensated Heart Failure. A Randomized Controlled Trial (USA-HF)
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 17, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. length of hospital stay (days) [Immediately after discharge]

    number of days from admission to discharge

Secondary Outcome Measures

  1. 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]

    Follow up telephone call after discharge

  2. 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]

    assessment of readmission to hospital

  3. percent change in GFR [One month after original discharge]

    amount of change in GFR

  4. hospitalization Cost [immediately after discharge of hospitalization]

    hospitalization cost measured for all hospitalization stay from admission to discharge for each participant

  5. Time to readmission [assessed within 4 weeks from index admission (i.e. thirty days readmission)]

    time between original hospitalization and readmission

  6. Number of right heart catheterization in each group and percentage of right heart catheterization in each group [One month after admission]

    document what procedures were done

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Texas Medical BranchGalvestonTexasUnited States77555

Sponsors and Collaborators

  • The University of Texas Medical Branch, Galveston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT04376424
Other Study ID Numbers:
  • 19-0276
First Posted:
May 6, 2020
Last Update Posted:
Nov 30, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2021