HEMOTAG® Assessment for Short-term Outcomes of Heart Failure (HATS-OFF)

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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure (HF)
• Intervention / Treatment: Diagnostic test: Standard of Care with Hemotag

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cindy Kober; Phone Number: 561-945-9303; Email: cindy@aventusoft.com
• Study Contact Backup: Name: Kaustubh Kale; Phone Number: 954-399-3335; Email: kaustubh@aventusoft.com

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
      • Contact: Cecilia Calvo
      • Principal Investigator: David Snipelisky
      • Contact: Diana Yanez, BSN,RN
  • Texas
    • Temple, Texas, United States, 76508
      • Recruiting
      • Baylor Scott & White Research Institute
      • Contact: Amy M Watts, BSN,RN
      • Principal Investigator: Jamie Hernandez-Montfort, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Randomized Standard of Care; Standard of Care
Active Comparator: Randomized Standard of Care with HEMOTAG; Standard of Care with HEMOTAG	Diagnostic test: Standard of Care with Hemotag; Comparison of outcomes; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of recurrent HF readmissions. [Monitoring period: 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]	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.	Time from discharge to the first event of HF readmissions or ER visits [Monitoring period: Event time assessed up to 3 months and 6 months from time of participant's discharge from initial study hospitalization.]	6 Months
Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months]	Total number of total days lost to hospitalization or ER visit due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months from time of participant's discharge from index hospitalization.]	6 Months
Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]	Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months from time of participant's discharge from initial study hospitalization.]	6 Months
Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)	Incidence of skin irritation [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use of device.)	30 Days

Collaborators and Investigators

• Sponsor: Aventusoft, LLC.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Cleveland Clinic Florida
• Investigators: Principal Investigator: David Snipelisky, MD, Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 20192767/HT-17-VV-020; 1R44HL145941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No