Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

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).

Study Overview

• Status: Completed
• Conditions: NYHA Class III Heart Failure
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17603
      • Lancaster General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients who have a cardioMEMS device

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device	Changes of body fluid levels in heart failure patients	From baseline through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ratio of thoracic ECF/TBW	Changes of thoracic fluid levels in heart failure patients	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	From baseline through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: ImpediMed Limited
• Collaborators: Scripps Health; Baim Institute for Clinical Research
• Investigators: Principal Investigator: Roy Small, MD, Lancaster General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): June 25, 2019

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Bioimpedance spectroscopy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IPD-SOZO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study, no individual participant data will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes