Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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).
- * 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
22 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No