HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

NCT04149743 | Recruiting DMC FDA Device

• 2 other identifiers: 20192767/HT-17-VV-0201R44HL145941
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Heart Failure (HF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.

  6 Months

• Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months]

  6 Months

• Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]

  6 Months

• Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)

  30 Days

Study Arms (2)

Randomized Standard of Care

NO INTERVENTION

Standard of Care

Randomized Standard of Care with HEMOTAG

ACTIVE COMPARATOR

Standard of Care with HEMOTAG

Diagnostic Test: Standard of Care with Hemotag

Interventions

Standard of Care with Hemotag DIAGNOSTIC_TEST

Comparison of outcomes

Also known as: Standard of Care

Randomized Standard of Care with HEMOTAG

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Aventusoft, LLC.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Cleveland Clinic Florida: collaborator

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Baylor Scott & White Research Institute

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• David Snipelisky, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Kober

CONTACT

561-945-9303; cindy@aventusoft.com

Kaustubh Kale

CONTACT

954-399-3335; kaustubh@aventusoft.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: January 31, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)