NYHA Class III Heart FailureNCT02939053
Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
An observational study of NYHA Class III Heart Failure, run by ImpediMed Limited at 2 sites in United States.
Trial summary
This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NYHA Class III Heart Failure
- What is being tested?
- SOZO
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Aug 2017to 25 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients who have a cardioMEMS device
Who may be able to join
- Age 18 years or older.
- NYHA Class III HF.
- Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
- Patient is characterized by at least one of the following:
- CardioMEMS implanted within the previous 90 days
- Received treatment with intravenous diuretics within the previous 30 days
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- Received dose escalation of oral diuretics at least twice within the previous 30 days
- Patient is able to sit upright for BIS measurements.
- Patient provides written informed consent and authorization to use and disclose health information.
Who cannot join
- 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 is pregnant or lactating.
- Patient has nephrotic syndrome or nephrosis.
- Patient has estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
- Patient has been diagnosed with lymphedema.
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- Patient has chronic liver failure or cirrhosis.
- Patient has a moderate or large pleural effusion as seen on chest X-ray.
- Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days.
- Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator).
- Patient has an amputation of a limb.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lancaster General Hospital
Lancaster, Pennsylvania, 17603
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System
This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical).
Read the detailed description
This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll thirty participants. Participants will be monitored daily at home for a period of 30 days. Each day, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's weight will also be taken each day.
- Conditions
- NYHA Class III Heart Failure
- Being tested
- SOZO
- Keywords
- Bioimpedance spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOZODevice
The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | All subjects enrolled will undergo measurements with the SOZO device daily for 30 days. Receives: Device: SOZO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device
Changes of body fluid levels in heart failure patients
Measured: From baseline through study completion, an average of 30 days
Secondary outcomes (2)
Change in the ratio of thoracic ECF/TBW
Changes of thoracic fluid levels in heart failure patients
Measured: From baseline through study completion, an average of 30 days
Change in the ratio of lower extremity ECF/TBW
Changes of lower limb fluid levels in heart failure patients
Measured: From baseline through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start29 Aug 2017
- Primary completion3 May 2018
- Study completion25 Jun 2019
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 NYHA Class III 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImpediMed Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research, Scripps Health
- Responsible party
- Sponsor
- Investigators
- Roy Small, MD, Principal investigator, Lancaster General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939053
- Sponsor's protocol ID
- IPD-SOZO-01
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a pilot study, no individual participant data will be made available.
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 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System
- ClinicalTrials.gov ID
- NCT02939053
- Acronym / sponsor ID
- IPD-SOZO-01
- Conditions
- NYHA Class III Heart Failure
- Keywords
- Bioimpedance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ImpediMed LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research, Scripps Health
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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 study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical).
Detailed description
This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll thirty participants. Participants will be monitored daily at home for a period of 30 days. Each day, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's weight will also be taken each day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | – | Device: SOZOAll subjects enrolled will undergo measurements with the SOZO device daily for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients who have a cardioMEMS device
Key inclusion criteria (9 listed)
- Age 18 years or older.
- NYHA Class III HF.
- Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
- Patient is characterized by at least one of the following:
- Patient is able to sit upright for BIS measurements.
Key exclusion criteria (11 listed)
- 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 is pregnant or lactating.
- Patient has nephrotic syndrome or nephrosis.
- Patient has estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
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 |
|---|---|---|
| SOZOThe SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters. | Device | Single-arm |
Primary outcome
Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device
Time frame: From baseline through study completion, an average of 30 days
Changes of body fluid levels in heart failure patients
2 secondary outcomes
Change in the ratio of thoracic ECF/TBW
Time frame: From baseline through study completion, an average of 30 days
Change in the ratio of lower extremity ECF/TBW
Time frame: From baseline through study completion, an average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- 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. This is a pilot study, no individual participant data will be made available.
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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.
Roy Small, MD principal investigator
Lancaster General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NYHA Class III Heart Failure, run by ImpediMed Limited at 2 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device (time frame: From baseline through study completion, an average of 30 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 NCT02939053, 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 8 Jul 2019.