HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Purpose
Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.
Condition
- Heart Failure (HF)
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age greater than or equal to 22 years old. - An index hospital admission for ADHF presenting with symptoms, clinical signs, and chest x-ray (CXR) findings of pulmonary congestion, receiving IV diuretics or vasoactive drugs and having a BNP > 350 or NT-pro BNP > 1800 pg/ml. - Able to give informed consent. - Participant's residence has adequate cellular data coverage. - Participants with previous diagnosis of left ventricular ejection fraction (LVEF) <40% prior to the index hospitalization must have been treated for at least 90 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contraindicated) and an ACE inhibitor or ARB or ARNi (unless intolerant or contraindicated).
Exclusion Criteria
- Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.) - Terminal condition with life expectancy less than 6 months as determined by investigator. - Participants with cardiac tamponade or constrictive pericarditis. - Participants with left ventricular assistance device (LVAD device) or had a cardiac transplantation or listed for transplantation. - Implantation of a CRT (cardiac resynchronization therapy) device during index hospitalization or intent to implant a CRT device. - Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation, as determined by investigator. - Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis, as determined by investigator. - Severe primary pulmonary, renal or hepatic disease, as determined by investigator. - Women of childbearing age (Age <50). - History of pulmonary embolism of less than 3 months. - Dialysis dependent or dialysis initiation expected within three months. - Chronic home IV therapy or cardiac inotropes or diuretics. - Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment. - Illness/ Condition which may be aggravated or cause significant discomfort by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes). - Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment. - Congenital heart malformations (Complex, or uncorrected congenital heart disease). - Participant enrolled in another interventional study (observational or registries are not excluded). - Participant HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, lung fluid monitoring. BNP/pro-BNP or bioimpedance or ICD or biventricular pacemaker with impedance monitoring will be allowed unless it is part of another research protocol). - Prisoners and wards of the state. - Inability to provide informed consent (Must speak English or Spanish or Creole).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Randomized Standard of Care |
Standard of Care |
|
|
Active Comparator Randomized Standard of Care with HEMOTAG |
Standard of Care with HEMOTAG |
|
Recruiting Locations
Cleveland Clinic Florida
Weston, Florida 33331
Weston, Florida 33331
Contact:
Diana Yanez, BSN,RN
Diana Yanez, BSN,RN
Baylor Scott & White Research Institute
Temple, Texas 76508
Temple, Texas 76508
Contact:
Amy M Watts, BSN,RN
Amy M Watts, BSN,RN
More Details
- Status
- Recruiting
- Sponsor
- Aventusoft, LLC.
Detailed Description
The overall objective of research is to test, adapt, refine and validate the HEMOTAG® system to be used outside the usual medical care environments to reduce hospital readmissions.