Quality of Life Improvement, Therapy Titration, Readmission Reduction through Bloodless Estimation in 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
- Jacksonville, Florida: 23-008984
About this study
The purpose of this study is to provide better understanding of the functional changes that accompany heart failure by using the CardioID platform.
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 between 18-74 years of age.
- Documented EF ≤ 40% by any method within 12 months prior to randomization.
- NYHA functional class III.
- Patients willing to comply with wearable monitoring and agree on data handling policy.
- Patient must be smartphone owner.
Exclusion Criteria:
- Recent diagnosis of ACS or cardiac revascularization within 30 days.
- CRT within prior 3 months or current plans to implant CRT device.
- Severe stenotic valvular disease.
- Expected transplant or left ventricular assist device implantation in the next 6 months.
- Chronic inotropic therapy.
- End-stage renal disease with renal replacement therapy.
- Patients with visual or cognitive impairment that are unable to consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/11/23. Questions regarding updates should be directed to the study team contact.
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Rohan Goswami, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available