Home-Based Fluid Status Monitoring in Heart Failure Patients

Terminated

• Conditions: Heart Failure
• Interventions: Device: SOZO Bioimpedance Spectroscopy Device

• Registration Number: NCT04013373
• Lead Sponsor: ImpediMed Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-09
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-09
• Primary Completion: 2020-07-30
• Study Completion: 2021-07-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIS home-based monitoring	SOZO Bioimpedance Spectroscopy Device	-

Primary Outcome Measures

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

Trial Locations

Locations (15)

MD Strategies Research Centers; 🇺🇸 National City, California, United States

Du Cardiology; 🇺🇸 Encinitas, California, United States

Blue Coast Cardiology; 🇺🇸 Vista, California, United States

Alliance Research Institute; 🇺🇸 Canoga Park, California, United States

Amavita Health; 🇺🇸 North Miami Beach, Florida, United States

Heart Care Associates; 🇺🇸 Oceanside, California, United States

San Diego Cardiovascular Associates; 🇺🇸 Encinitas, California, United States

SC Clinical Research; 🇺🇸 Garden Grove, California, United States

Scripps Clinic, John R. Anderson V Medical Pavilion; 🇺🇸 La Jolla, California, United States

Flint Cardiovascular; 🇺🇸 Flint, Michigan, United States

Research Alliance; 🇺🇸 Clearwater, Florida, United States

Infinite Clinical Research; 🇺🇸 Doral, Florida, United States

Broward Research Center; 🇺🇸 Pembroke Pines, Florida, United States

International Research Associates; 🇺🇸 Miami, Florida, United States

Sierra Clinical Research; 🇺🇸 Las Vegas, Nevada, United States