Heart FailureNCT04013373
Home-Based Fluid Status Monitoring in Heart Failure Patients
An observational study of Heart Failure, run by ImpediMed Limited at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SOZO Bioimpedance Spectroscopy Device
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 Oct 2018to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are being discharged home from a hospitalization for heart failure
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Alliance Research Institute
Canoga Park, California, 91304
Research Alliance
Clearwater, Florida, 33756
Infinite Clinical Research
Doral, Florida, 33126
Du Cardiology
Encinitas, California, 92024
San Diego Cardiovascular Associates
Encinitas, California, 92024
Flint Cardiovascular
Flint, Michigan, 48532
SC Clinical Research
Garden Grove, California, 92844
Scripps Clinic, John R. Anderson V Medical Pavilion
La Jolla, California, 92037
Sierra Clinical Research
Las Vegas, Nevada, 89106
International Research Associates
Miami, Florida, 33183
MD Strategies Research Centers
National City, California, 91950
Amavita Health
North Miami Beach, Florida, 33169
Heart Care Associates
Oceanside, California, 92056
Broward Research Center
Pembroke Pines, Florida, 33024
Blue Coast Cardiology
Vista, California, 92083
About this study
Official title: Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
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.
- Conditions
- Heart Failure
- Being tested
- SOZO Bioimpedance Spectroscopy Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOZO Bioimpedance Spectroscopy DeviceDevice
Bioimpedance spectroscopy measurements for assessment of fluid status
| Study group | Role | What they receive |
|---|---|---|
| BIS home-based monitoring | Not described Receives: Device: SOZO Bioimpedance Spectroscopy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water
Characterize BIS trends that precede hospital readmissions for heart failure
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start9 Oct 2018
- Primary completion30 Jul 2020
- Study completion30 Jul 2021
Why it stopped: Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImpediMed Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James T Heywood, MD, Principal investigator, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013373
- Sponsor's protocol ID
- IPD-HBHF-001
- Status last verified
- Aug 2021
- First submitted
- 5 Jul 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 33898536
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
- ClinicalTrials.gov ID
- NCT04013373
- Acronym / sponsor ID
- IPD-HBHF-001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19 pandemic
- Enrolment
- 92 participants (actual)
- Lead sponsor
- ImpediMed LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS home-based monitoring | – | Device: SOZO Bioimpedance Spectroscopy Device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are being discharged home from a hospitalization for heart failure
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOZO Bioimpedance Spectroscopy DeviceBioimpedance spectroscopy measurements for assessment of fluid status | Device | BIS home-based monitoring |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 33898536Accardi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Heywood, MD principal investigator
Scripps Clinic
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by ImpediMed Limited at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.