Condition or disease | Intervention/treatment |
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Heart Failure | Device: SOZO Bioimpedance Spectroscopy Device |
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 |
Group/Cohort | Intervention/treatment |
---|---|
BIS home-based monitoring |
Device: SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status
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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 |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | James T Heywood, MD | Scripps Clinic |
Tracking Information | |||||||
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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 |
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
|
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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 |
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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
|
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Study Groups/Cohorts | BIS home-based monitoring
Intervention: Device: SOZO Bioimpedance Spectroscopy Device
|
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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. |
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Recruitment Information | |||||||
Recruitment Status | Suspended | ||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | ImpediMed Limited | ||||||
Study Sponsor | ImpediMed Limited | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | ImpediMed Limited | ||||||
Verification Date | July 2020 |