Using HEMOTAG® to improve heart failure outcomes

HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]

This study is testing if the HEMOTAG® system can help people with heart failure manage their condition better and avoid going back to the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Aventusoft, LLC. (Industry-sponsored)
• Locations: 2 sites (Weston, Florida and 1 other locations)
• Trial ID: NCT04149743 on ClinicalTrials.gov

What this trial studies

This study evaluates the HEMOTAG® system in a real-world setting to assess its effectiveness in managing heart failure. The goal is to adapt and validate the system for use by patients outside traditional medical environments, aiming to reduce hospital readmissions. Participants will receive standard care alongside the HEMOTAG® intervention, which monitors their condition. The study focuses on patients who have experienced acute decompensated heart failure and meet specific clinical criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older who have been hospitalized for acute decompensated heart failure and meet specific clinical criteria.

Not a fit: Patients with terminal conditions or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce hospital readmissions for heart failure patients.

How similar studies have performed: Other studies have shown promise in using technology for heart failure management, suggesting potential success for this approach.

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).

Where this trial is running

Weston, Florida and 1 other locations

• Cleveland Clinic Florida — Weston, Florida, United States (Recruiting)
• Baylor Scott & White Research Institute — Temple, Texas, United States (Recruiting)

Study contacts

• Principal investigator: David Snipelisky, MD — Cleveland Clinic Florida
• Study coordinator: Cindy Kober

Conditions Heart Failure