Status:
TERMINATED
Home-Based Fluid Status Monitoring in Heart Failure Patients
Lead Sponsor:
ImpediMed Limited
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
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, patien...
Eligibility Criteria
Inclusion
- Age 21 years or older
- NYHA Class II or III at the time of study enrollment
- Undergoing discharge following hospitalization for acute heart failure
- Planned continued treatment for heart failure
- Patient is able to stand or sit upright for bioimpedance spectroscopy measurements
- Patient reports access to reliable Wi-Fi connection at home
- Patient reports adequate space for the SOZO device at home
- Patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures
Exclusion
- Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator)
- Patient has a confirmed diagnosis of acute coronary syndrome during current admission
- 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
- Patient has a clinical condition that would not allow them to complete the study
- Patient has had surgical revascularization using saphenous vein grafting that may affect venous return
- Patient is pregnant or lactating
- Patient has nephrotic syndrome or nephrosis
- Patient has end-stage renal disease requiring chronic dialysis
- Patient has been diagnosed with lymphedema
- Patient has chronic liver failure or cirrhosis
- Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days
- Patient has an amputation of a limb \[Exception: amputation of digits may not affect bioimpedance spectroscopy measurements and will be permitted at the discretion of the study sponsor\]
- 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
Key Trial Info
Start Date :
October 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04013373
Start Date
October 9 2018
End Date
July 30 2021
Last Update
August 25 2021
Active Locations (15)
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1
Alliance Research Institute
Canoga Park, California, United States, 91304
2
Du Cardiology
Encinitas, California, United States, 92024
3
San Diego Cardiovascular Associates
Encinitas, California, United States, 92024
4
SC Clinical Research
Garden Grove, California, United States, 92844