Home-Based Fluid Status Monitoring in Heart Failure Patients

Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure

This is a prospective, multi-center, single-arm study enrolling adult patients who have been hospitalized for heart failure and subsequently discharged. For the duration of study participation, patients will obtain daily at-home bioimpedance measurements. Heart failure symptoms, medications, and re-hospitalizations will be tracked. Additionally, quality of life questionnaires will be administered at the beginning and end of study participation.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: SOZO Bioimpedance Spectroscopy Device

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• United States
  • California
    • Canoga Park, California, United States, 91304
      • Alliance Research Institute
    • Encinitas, California, United States, 92024
      • Du Cardiology
    • Encinitas, California, United States, 92024
      • San Diego Cardiovascular Associates
    • Garden Grove, California, United States, 92844
      • SC Clinical Research
    • La Jolla, California, United States, 92037
      • Scripps Clinic, John R. Anderson V Medical Pavilion
    • National City, California, United States, 91950
      • MD Strategies Research Centers
    • Oceanside, California, United States, 92056
      • Heart Care Associates
    • Vista, California, United States, 92083
      • Blue Coast Cardiology
  • Florida
    • Clearwater, Florida, United States, 33756
      • Research Alliance
    • Doral, Florida, United States, 33126
      • Infinite Clinical Research
    • Miami, Florida, United States, 33183
      • International Research Associates
    • North Miami Beach, Florida, United States, 33169
      • Amavita Health
    • Pembroke Pines, Florida, United States, 33024
      • Broward Research Center
  • Michigan
    • Flint, Michigan, United States, 48532
      • Flint Cardiovascular
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are being discharged home from a hospitalization for heart failure

Description

Inclusion Criteria:

1. Age 21 years or older
2. NYHA Class II or III at the time of study enrollment
3. Undergoing discharge following hospitalization for acute heart failure
4. Planned continued treatment for heart failure
5. Patient is able to stand or sit upright for bioimpedance spectroscopy measurements
6. Patient reports access to reliable Wi-Fi connection at home
7. Patient reports adequate space for the SOZO device at home
8. Patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures

Exclusion Criteria:

1. Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator)
2. Patient has a confirmed diagnosis of acute coronary syndrome during current admission
3. Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion
4. Patient has a clinical condition that would not allow them to complete the study
5. Patient has had surgical revascularization using saphenous vein grafting that may affect venous return
6. Patient is pregnant or lactating
7. Patient has nephrotic syndrome or nephrosis
8. Patient has end-stage renal disease requiring chronic dialysis
9. Patient has been diagnosed with lymphedema
10. Patient has chronic liver failure or cirrhosis
11. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days
12. Patient has an amputation of a limb [Exception: amputation of digits may not affect bioimpedance spectroscopy measurements and will be permitted at the discretion of the study sponsor]
13. Patient has any other medical condition that, in the opinion of the investigator, will impair the subject's ability to complete study procedures or participate in the protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BIS home-based monitoring	Device: SOZO Bioimpedance Spectroscopy Device; Bioimpedance spectroscopy measurements for assessment of fluid status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water	Characterize BIS trends that precede hospital readmissions for heart failure	45 days

Collaborators and Investigators

• Sponsor: ImpediMed Limited

Publications and helpful links

General Publications

• Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2018
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (ACTUAL): July 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IPD-HBHF-001

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
• product manufactured in and exported from the U.S.: Yes