Study Stopped
Covid-19 pandemic
Home-Based Fluid Status Monitoring in Heart Failure Patients
1 other identifier
observational
92
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2018
CompletedFirst Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedAugust 25, 2021
August 1, 2021
1.8 years
July 5, 2019
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water
Characterize BIS trends that precede hospital readmissions for heart failure
45 days
Study Arms (1)
BIS home-based monitoring
Interventions
Bioimpedance spectroscopy measurements for assessment of fluid status
Eligibility Criteria
Adult patients who are being discharged home from a hospitalization for heart failure
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Alliance Research Institute
Canoga Park, California, 91304, United States
Du Cardiology
Encinitas, California, 92024, United States
San Diego Cardiovascular Associates
Encinitas, California, 92024, United States
SC Clinical Research
Garden Grove, California, 92844, United States
Scripps Clinic, John R. Anderson V Medical Pavilion
La Jolla, California, 92037, United States
MD Strategies Research Centers
National City, California, 91950, United States
Heart Care Associates
Oceanside, California, 92056, United States
Blue Coast Cardiology
Vista, California, 92083, United States
Research Alliance
Clearwater, Florida, 33756, United States
Infinite Clinical Research
Doral, Florida, 33126, United States
International Research Associates
Miami, Florida, 33183, United States
Amavita Health
North Miami Beach, Florida, 33169, United States
Broward Research Center
Pembroke Pines, Florida, 33024, United States
Flint Cardiovascular
Flint, Michigan, 48532, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Related Publications (1)
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.
PMID: 33898536DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James T Heywood, MD
Scripps Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 9, 2019
Study Start
October 9, 2018
Primary Completion
July 30, 2020
Study Completion
July 30, 2021
Last Updated
August 25, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share