HEMOTAG® Assessment for Short-term Outcomes of Heart Failure (HATS-OFF)

Aventusoft

Status

Enrolling

Conditions

Heart Failure (HF)

Treatments

Diagnostic Test: Standard of Care with Hemotag

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT04149743

20192767/HT-17-VV-020

1R44HL145941 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

420 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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).