Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

NYHA Class III Heart Failure Clinical Trial

Official title:

Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939053
• Other study ID #: IPD-SOZO-01
• Status: Completed
• Start date: August 29, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2019
• Source: ImpediMed Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 25, 2019
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• NYHA Class III Heart Failure

Intervention

Device:
• SOZO
The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters.

Locations

Country	Name	City	State
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
ImpediMed Limited	Baim Institute for Clinical Research, Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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