HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

Study Overview
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Brief Summary
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Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.

Detailed Description
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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.

Official Title
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HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]

Conditions
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Heart Failure (HF)

Intervention / Treatment
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* Diagnostic Test: Standard of Care with Hemotag


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Randomized Standard of Care<br>Standard of Care | |
| Active Comparator: Randomized Standard of Care with HEMOTAG<br>Standard of Care with HEMOTAG | Diagnostic Test: Standard of Care with Hemotag<br>* Comparison of outcomes<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of recurrent HF readmissions. [Monitoring period: 30 days] | Determine if HEMOTAG can reduce the relative number of HF readmissions or ER visits versus standard of care. [Monitoring period: 30 days from time of participant's discharge from initial index hospitalization] | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge. | Time from discharge to the first event of HF readmissions or ER visits [Monitoring period: Event time assessed up to 3 months and 6 months from time of participant's discharge from initial study hospitalization.] | 6 Months | 
| Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months] | Total number of total days lost to hospitalization or ER visit due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months from time of participant's discharge from index hospitalization.] | 6 Months | 
| Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months] | Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months from time of participant's discharge from initial study hospitalization.] | 6 Months | 
| Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.) | Incidence of skin irritation [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use of device.) | 30 Days |