Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

NCT02939053 | Completed FDA Device

• 1 other identifier: IPD-SOZO-01
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

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).

Conditions

NYHA Class III Heart Failure

Keywords

Bioimpedance spectroscopy

Outcome Measures

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

  From baseline through study completion, an average of 30 days

Secondary Outcomes (2)

• Change in the ratio of thoracic ECF/TBW

  From baseline through study completion, an average of 30 days

• Change in the ratio of lower extremity ECF/TBW

  From baseline through study completion, an average of 30 days

Study Arms (1)

Single-arm

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

Device: SOZO

Interventions

SOZO DEVICE

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

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients who have a cardioMEMS device

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImpediMed Limited: lead
• Baim Institute for Clinical Research: collaborator
• Scripps Health: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17603, United States

Location

Related Publications (1)

• 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.

  PMID: 33898536 DERIVED

Study Officials

• Roy Small, MD

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 19, 2016
• Study Start: August 29, 2017
• Primary Completion: May 3, 2018
• Study Completion: June 25, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)