HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

Recruiting now · Not applicable

Conditions studied: Heart Failure (HF)

In brief

Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.

Key facts

Study ID

NCT04149743

Run by

Aventusoft, LLC.

People needed

420

Starts

2022-01-31

Expected to finish

2024-12-01

Last updated by the study team

2024-08-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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