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CompletedNCT02939053Updated Jul 8, 2019

Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

An observational study in NYHA Class III Heart Failure, sponsored by ImpediMed Limited. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by ImpediMed Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • NYHA Class III Heart Failure

Keywords

  • Bioimpedance spectroscopy
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In context

Lead sponsor

ImpediMed Limited is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heart failure patients who have a cardioMEMS device

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years or older.
  2. NYHA Class III HF.
  3. Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
  4. 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
    • Received dose escalation of oral diuretics at least twice within the previous 30 days
  5. Patient is able to sit upright for BIS measurements.
  6. Patient provides written informed consent and authorization to use and disclose health information.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patient has a clinical condition that would not allow them to complete the study.
  3. Patient is pregnant or lactating.
  4. Patient has nephrotic syndrome or nephrosis.
  5. Patient has estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
  6. Patient has been diagnosed with lymphedema.
  7. Patient has chronic liver failure or cirrhosis.
  8. Patient has a moderate or large pleural effusion as seen on chest X-ray.
  9. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days.
  10. Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator).
  11. Patient has an amputation of a limb.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No

Groups and cohorts

  • Single-arm

    All subjects enrolled will undergo measurements with the SOZO device daily for 30 days.

    Device: SOZO

Interventions

  • DeviceSOZO

    The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters.

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What researchers measure

Primary outcomes

  1. Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device

    Changes of body fluid levels in heart failure patients

    Time frame: From baseline through study completion, an average of 30 days

Secondary outcomes

  1. Change in the ratio of thoracic ECF/TBW

    Changes of thoracic fluid levels in heart failure patients

    Time frame: From baseline through study completion, an average of 30 days

  2. Change in the ratio of lower extremity ECF/TBW

    Changes of lower limb fluid levels in heart failure patients

    Time frame: From baseline through study completion, an average of 30 days

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Study locations

2 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Lancaster General Hospital
    Lancaster, Pennsylvania 17603, United States
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References and documents

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 ↗

Individual participant data

Plan to share: No — This is a pilot study, no individual participant data will be made available.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02939053
Lead sponsor
ImpediMed Limited
Collaborators
Baim Institute for Clinical Research, Scripps Health
Responsible party
Sponsor
First posted
Oct 19, 2016
Start date
Aug 29, 2017
Primary completion
May 3, 2018
Completion
Jun 25, 2019
Last update
Jul 8, 2019

Study contacts

Roy Small, MD
principal investigator · Lancaster General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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