Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009174
NCT ID: NCT02939053
Sponsor Protocol Number: 16-009174
About this study
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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Grace Lin, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available