HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure (HF)

• Registration Number: NCT04149743
• Lead Sponsor: Aventusoft, LLC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Inclusion Criteria:<br><br> - Age greater than or equal to 22 years old.<br><br> - An index hospital admission for ADHF presenting with symptoms, clinical signs, and<br> chest x-ray (CXR) findings of pulmonary congestion, receiving IV diuretics or<br> vasoactive drugs and having a BNP > 350 or NT-pro BNP > 1800 pg/ml.<br><br> - Able to give informed consent.<br><br> - Participant's residence has adequate cellular data coverage.<br><br> - Participants with previous diagnosis of left ventricular ejection fraction (LVEF)<br> <40% prior to the index hospitalization must have been treated for at least 90 days<br> prior to enrollment with diuretics and beta-blocker (unless intolerant or<br> contraindicated) and an ACE inhibitor or ARB or ARNi (unless intolerant or<br> contraindicated).<br><br>Exclusion Criteria:<br><br> - Participants unable to provide informed, voluntary decision to participate in<br> research study as determined by the investigator. (Exclude participants who<br> necessitate the involvement of a legally authorized representative.)<br><br> - Terminal condition with life expectancy less than 6 months as determined by<br> investigator.<br><br> - Participants with cardiac tamponade or constrictive pericarditis.<br><br> - Participants with left ventricular assistance device (LVAD device) or had a cardiac<br> transplantation or listed for transplantation.<br><br> - Implantation of a CRT (cardiac resynchronization therapy) device during index<br> hospitalization or intent to implant a CRT device.<br><br> - Presence of hemodynamically significant mitral and/or aortic valve disease, except<br> mitral regurgitation secondary to left ventricular dilatation, as determined by<br> investigator.<br><br> - Presence of hemodynamically significant obstructive lesions of left ventricular<br> outflow tract, including aortic and sub-aortic stenosis, as determined by<br> investigator.<br><br> - Severe primary pulmonary, renal or hepatic disease, as determined by investigator.<br><br> - Women of childbearing age (Age <50).<br><br> - History of pulmonary embolism of less than 3 months.<br><br> - Dialysis dependent or dialysis initiation expected within three months.<br><br> - Chronic home IV therapy or cardiac inotropes or diuretics.<br><br> - Physical deformity in the chest area or lesion that may prevent proper HEMOTAG<br> application or adjustment.<br><br> - Illness/ Condition which may be aggravated or cause significant discomfort by the<br> application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin<br> electrodes).<br><br> - Impaired cognitive ability or any other state that may prevent full compliance with<br> the study protocol, according to investigator's assessment.<br><br> - Congenital heart malformations (Complex, or uncorrected congenital heart disease).<br><br> - Participant enrolled in another interventional study (observational or registries<br> are not excluded).<br><br> - Participant HF is managed remotely with another monitoring device or program (for<br> example: Pulmonary/ Lt Atrial pressure monitoring, lung fluid monitoring.<br> BNP/pro-BNP or bioimpedance or ICD or biventricular pacemaker with impedance<br> monitoring will be allowed unless it is part of another research protocol).<br><br> - Prisoners and wards of the state.<br><br> - Inability to provide informed consent (Must speak English or Spanish or Creole).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of recurrent HF readmissions. [Monitoring period: 30 days]

Secondary Outcome Measures

Name	Time	Method
Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.;Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months];Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months];Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)