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出境医 / 临床实验 / Home-Based Fluid Status Monitoring in Heart Failure Patients

Home-Based Fluid Status Monitoring in Heart Failure Patients

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure Device: SOZO Bioimpedance Spectroscopy Device

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
BIS home-based monitoring Device: SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status

Outcome Measures
Primary Outcome Measures :
  1. Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water [ Time Frame: 45 days ]
    Characterize BIS trends that precede hospital readmissions for heart failure


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who are being discharged home from a hospitalization for heart failure
Criteria

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
Contacts and Locations

Locations
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United States, California
Alliance Research Institute
Canoga Park, California, United States, 91304
Du Cardiology
Encinitas, California, United States, 92024
San Diego Cardiovascular Associates
Encinitas, California, United States, 92024
SC Clinical Research
Garden Grove, California, United States, 92844
Scripps Clinic, John R. Anderson V Medical Pavilion
La Jolla, California, United States, 92037
MD Strategies Research Centers
National City, California, United States, 91950
Heart Care Associates
Oceanside, California, United States, 92056
Blue Coast Cardiology
Vista, California, United States, 92083
United States, Florida
Research Alliance
Clearwater, Florida, United States, 33756
Infinite Clinical Research
Doral, Florida, United States, 33126
International Research Associates
Miami, Florida, United States, 33183
Amavita Health
North Miami Beach, Florida, United States, 33169
Broward Research Center
Pembroke Pines, Florida, United States, 33024
United States, Michigan
Flint Cardiovascular
Flint, Michigan, United States, 48532
United States, Nevada
Sierra Clinical Research
Las Vegas, Nevada, United States, 89106
Sponsors and Collaborators
ImpediMed Limited
Investigators
Layout table for investigator information
Principal Investigator: James T Heywood, MD Scripps Clinic
Tracking Information
First Submitted Date July 5, 2019
First Posted Date July 9, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date October 9, 2018
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019)
Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water [ Time Frame: 45 days ]
Characterize BIS trends that precede hospital readmissions for heart failure
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Home-Based Fluid Status Monitoring in Heart Failure Patients
Official Title Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients who are being discharged home from a hospitalization for heart failure
Condition Heart Failure
Intervention Device: SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status
Study Groups/Cohorts BIS home-based monitoring
Intervention: Device: SOZO Bioimpedance Spectroscopy Device
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: July 8, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04013373
Other Study ID Numbers IPD-HBHF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ImpediMed Limited
Study Sponsor ImpediMed Limited
Collaborators Not Provided
Investigators
Principal Investigator: James T Heywood, MD Scripps Clinic
PRS Account ImpediMed Limited
Verification Date July 2020