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Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

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ClinicalTrials.gov Identifier: NCT02939053
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Baim Institute for Clinical Research
Scripps Health
Information provided by (Responsible Party):
ImpediMed Limited

Brief 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).

Condition or disease Intervention/treatment
NYHA Class III Heart Failure Device: SOZO

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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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Single-arm
All subjects enrolled will undergo measurements with the SOZO device daily for 30 days.
Device: SOZO
The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in the ratio of thoracic ECF/TBW [ Time Frame: From baseline through study completion, an average of 30 days ]
    Changes of thoracic fluid levels in heart failure patients

  2. Change in the ratio of lower extremity ECF/TBW [ Time Frame: From baseline through study completion, an average of 30 days ]
    Changes of lower limb fluid levels in heart failure patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients who have a cardioMEMS device
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939053


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17603
Sponsors and Collaborators
ImpediMed Limited
Baim Institute for Clinical Research
Scripps Health
Investigators
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Principal Investigator: Roy Small, MD Lancaster General Hospital

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Responsible Party: ImpediMed Limited
ClinicalTrials.gov Identifier: NCT02939053     History of Changes
Other Study ID Numbers: IPD-SOZO-01
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a pilot study, no individual participant data will be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by ImpediMed Limited:
Bioimpedance spectroscopy

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases