Home-Based Fluid Status Monitoring in Heart Failure Patients
NCT ID: NCT04013373
Last Updated: 2021-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
92 participants
OBSERVATIONAL
2018-10-09
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BIS home-based monitoring
SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status
Interventions
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SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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ImpediMed Limited
INDUSTRY
Responsible Party
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Principal Investigators
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James T Heywood, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Clinic
Locations
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Alliance Research Institute
Canoga Park, California, United States
Du Cardiology
Encinitas, 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
MD Strategies Research Centers
National City, California, United States
Heart Care Associates
Oceanside, California, United States
Blue Coast Cardiology
Vista, California, United States
Research Alliance
Clearwater, Florida, United States
Infinite Clinical Research
Doral, Florida, United States
International Research Associates
Miami, Florida, United States
Amavita Health
North Miami Beach, Florida, United States
Broward Research Center
Pembroke Pines, Florida, United States
Flint Cardiovascular
Flint, Michigan, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Countries
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References
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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.
Other Identifiers
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IPD-HBHF-001
Identifier Type: -
Identifier Source: org_study_id
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