Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
Study Details
Study Description
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 | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device [From baseline through study completion, an average of 30 days]
Changes of body fluid levels in heart failure patients
Secondary Outcome Measures
- Change in the ratio of thoracic ECF/TBW [From baseline through study completion, an average of 30 days]
Changes of thoracic fluid levels in heart failure patients
- Change in the ratio of lower extremity ECF/TBW [From baseline through study completion, an average of 30 days]
Changes of lower limb fluid levels in heart failure patients
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older.
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NYHA Class III HF.
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Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
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Patient is characterized by at least one of the following:
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CardioMEMS implanted within the previous 90 days
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Received treatment with intravenous diuretics within the previous 30 days
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Received dose escalation of oral diuretics at least twice within the previous 30 days
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Patient is able to sit upright for BIS measurements.
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Patient provides written informed consent and authorization to use and disclose health information.
Exclusion Criteria:
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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.
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Patient has a clinical condition that would not allow them to complete the study.
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Patient is pregnant or lactating.
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Patient has nephrotic syndrome or nephrosis.
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Patient has estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
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Patient has been diagnosed with lymphedema.
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Patient has chronic liver failure or cirrhosis.
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Patient has a moderate or large pleural effusion as seen on chest X-ray.
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Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days.
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Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator).
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Patient has an amputation of a limb.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 2 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17603 |
Sponsors and Collaborators
- ImpediMed Limited
- Baim Institute for Clinical Research
- Scripps Health
Investigators
- Principal Investigator: Roy Small, MD, Lancaster General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IPD-SOZO-01