Home-Based Fluid Status Monitoring in Heart Failure Patients

ImpediMed

Status: Terminated

Conditions: Heart Failure

Treatments: Device: SOZO Bioimpedance Spectroscopy Device

Study type: Observational

Funder types: Industry

Identifiers

NCT04013373

IPD-HBHF-001

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

92 participants in 1 patient group

BIS home-based monitoring

Treatment:

Device: SOZO Bioimpedance Spectroscopy Device