Clinical trial NCT04149743: HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Official title: HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure (HF)
Lead sponsor: Aventusoft, LLC.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Cleveland Clinic Florida
First posted: 2019-11-04
Enrollment: 420
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The number of recurrent HF readmissions. [Monitoring period: 30 days]
timeFrame: 30 Days
Secondary outcomes:
measure: Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.
timeFrame: 6 Months
measure: Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months]
timeFrame: 6 Months
measure: Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]
timeFrame: 6 Months
measure: Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)
timeFrame: 30 Days
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Temple
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
affiliation: Cleveland Clinic Florida
name: David Snipelisky, MD
role: PRINCIPAL_INVESTIGATOR
References: