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

Primary Purpose

Heart Failure (HF)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care with Hemotag
Sponsored by
Aventusoft, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure (HF)

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • Patient's residence has adequate cellular data coverage.
  • Diagnosis of HF (Assessment of LV systolic function using transthoracic Echocardiogram, Gated SPECT, MUGA or right heart catheterization; during the index hospitalization or within the preceding 6 months).
  • Patients with LVEF <40% must have been treated at least 90 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contraindicated) and an ACE inhibitor or ARB (unless intolerant or contraindicated) or ANRI.

Exclusion Criteria:

  • Exclude enrollment by consent of a legally authorized representative.
  • Terminal condition with life expectancy less than 90 days.
  • Patients with cardiac tamponade or constrictive pericarditis.
  • Patients 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.
  • Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
  • Severe primary pulmonary, renal or hepatic disease.
  • Subjects pregnant or planning pregnancy within 1 month.
  • 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).
  • Severe disease / conditions with life expectancy <6 months according to investigator's assessment.
  • Patient is enrolled in another interventional study (observational or registries are not excluded).
  • Patient HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, lung fluid monitoring, Weight scale, BNP, bioimpedance or ICD with impedance).
  • Prisoners and wards of the state.
  • Inability to provide informed consent (English, Spanish, Creole).

Sites / Locations

  • Cleveland Clinic FloridaRecruiting
  • Baylor Scott & White Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Randomized Standard of Care

Randomized Standard of Care with HEMOTAG

Arm Description

Standard of Care

Standard of Care with HEMOTAG

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

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.]
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.]
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.]
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.)

Full Information

First Posted
October 29, 2019
Last Updated
August 11, 2023
Sponsor
Aventusoft, LLC.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Cleveland Clinic Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04149743
Brief Title
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Acronym
HATS-OFF
Official Title
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aventusoft, LLC.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Cleveland Clinic Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure (HF)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Randomized Standard of Care with HEMOTAG
Arm Type
Active Comparator
Arm Description
Standard of Care with HEMOTAG
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of Care with Hemotag
Other Intervention Name(s)
Standard of Care
Intervention Description
Comparison of outcomes
Primary Outcome Measure Information:
Title
The number of recurrent HF readmissions. [Monitoring period: 30 days]
Description
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]
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.
Description
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.]
Time Frame
6 Months
Title
Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months]
Description
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.]
Time Frame
6 Months
Title
Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]
Description
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.]
Time Frame
6 Months
Title
Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)
Description
Incidence of skin irritation [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use of device.)
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cindy Kober
Phone
561-945-9303
Email
cindy@aventusoft.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kaustubh Kale
Phone
954-399-3335
Email
kaustubh@aventusoft.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Snipelisky, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Yanez, BSN,RN
First Name & Middle Initial & Last Name & Degree
Cecilia Calvo
First Name & Middle Initial & Last Name & Degree
David Snipelisky
Facility Name
Baylor Scott & White Research Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy M Watts, BSN,RN
First Name & Middle Initial & Last Name & Degree
Jamie Hernandez-Montfort, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

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