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HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

NCT04149743 · Aventusoft, LLC.
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Official title
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]
About this study
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).
Study design
Enrollment target: 420 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-01-31
Estimated completion: 2024-12
Last updated: 2024-08-21
Interventions
Diagnostic Test: Standard of Care with Hemotag
Primary outcomes
  • The number of recurrent HF readmissions. [Monitoring period: 30 days] (30 Days)
Sponsor
Aventusoft, LLC. · industry
With: National Heart, Lung, and Blood Institute (NHLBI), Cleveland Clinic Florida
Contacts & investigators
ContactCindy Kober · contact · cindy@aventusoft.com · 561-945-9303
ContactKaustubh Kale · contact · kaustubh@aventusoft.com · 954-399-3335
InvestigatorDavid Snipelisky, MD · principal_investigator, Cleveland Clinic Florida
All locations (2)
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Baylor Scott & White Research InstituteRecruiting
Temple, Texas, United States
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure · TrialPath