A Study to Evaluate Home Monitoring of Post-Discharge Congestive Heart Failure Patients
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: 18-010525
Sponsor Protocol Number: 18-010525
About this study
The primary purpose of this study is to collect long-term (2-month duration) data with the ADI CHF Device on patients at home to demonstrate effectiveness of the device in accurately measuring biologically relevant parameters and detecting fluid status as compared to the standard of care (weight scale).
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:
- Adults over the age of 21 and who are willing and able to give informed consent.
- Willing to return for all follow-up visits and necessary medical care for duration of study (~8 weeks).
- Diagnosed with CHF and have experienced >1 CHF event in the past 12 months.
- Classified as NYHA Class I-IV within the past 12 months.
- Have cellular coverage in their homes.
- Fall within the 5th-95th percentile of chest circumference.
Exclusion Criteria:
- Under the age of 21.
- Physical or cognitive limitations that would prevent patient from applying or using the device properly.
- Women who are known to be pregnant or plan to become pregnant within the course of this study.
- Has known allergies to silicone based adhesive or skin breakdown in areas where device placement is required.
- Receiving dialysis with end-stage kidney disease.
- Participant and his/her immediate family members work for a medical device or pharmaceutical company.
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 Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available