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HEMOTAG® Assessment for Heart Failure Outcomes

This study is evaluating the HEMOTAG® system, a diagnostic tool, alongside standard care for people with heart failure (HF). Researchers want to see if using HEMOTAG® can help reduce how often people with heart failure need to be readmitted to the hospital. You might be able to join if you are at least 22 years old, have recently been hospitalized for acute decompensated heart failure (ADHF) with symptoms like fluid in your lungs, and have specific biomarker levels (BNP > 350 or NT-pro BNP > 1800 pg/ml). The study aims to enroll 420 participants and will measure how many times participants are readmitted for heart failure within 30 days.

Study design
This interventional study plans to enroll 420 participants to compare outcomes when using the HEMOTAG® system with standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 30 days to track recurrent heart failure readmissions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04149743

HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

UNKNOWN
NAAges 22+InterventionalDiagnostic
Aventusoft, LLC.
~420 participants
Updated 2024-08-21 on ClinicalTrials.gov
What's tested:Standard of Care with Hemotag

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of recurrent HF readmissions. [Monitoring period: 30 days]
Measured over 30 Days

Conditions

Heart Failure (HF)

Explore related trials

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NCT04149743

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor Scott & White Research Institute

    Temple, Texasno site contact published

    Recruiting

  • Cleveland Clinic Florida

    Weston, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • David Snipelisky, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Florida

Who to contact

Cindy Kober
[email protected]
561-945-9303
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • The number of recurrent HF readmissions. [Monitoring period: 30 days]30 Days

    Determine if HEMOTAG can reduce the relative number of HF readmissions or ER visits versus standard of care. \[Monitoring period: 30 days from time of participant's discharge from initial index hospitalization\]