| Condition or disease | Intervention/treatment |
|---|---|
| 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
|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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
|
||||||
| 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. |
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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 | ||||||