Heart Failure (HF)HATS-OFFNCT04149743
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
A study of Heart Failure (HF), run by Aventusoft, LLC. at 2 sites in United States.
Trial summary
Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart Failure (HF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Baylor Scott & White Research Institute
Temple, Texas, 76508
Amy M Watts, BSN,RN
Jamie Hernandez-Montfort, MD
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Diana Yanez, BSN,RN
Cecilia Calvo
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure (HF)
- Being tested
- Standard of Care with Hemotag
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care with HemotagDiagnostic test
Also called Standard of Care
Comparison of outcomes
| Study group | Role | What they receive |
|---|---|---|
| Randomized Standard of Care | No intervention | Standard of Care |
| Randomized Standard of Care with HEMOTAG | Active comparator | Standard of Care with HEMOTAG Receives: Diagnostic Test: Standard of Care with Hemotag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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.
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.]
Measured: 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.]
Measured: 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.]
Measured: 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.)
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start31 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventusoft, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cleveland Clinic Florida
- Responsible party
- Sponsor
- Investigators
- David Snipelisky, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149743
- Sponsor's protocol ID
- 20192767/HT-17-VV-020
- Other IDs
- 1R44HL145941
- Acronym
- HATS-OFF
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2019
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]
- ClinicalTrials.gov ID
- NCT04149743
- Acronym / sponsor ID
- HATS-OFF / 20192767/HT-17-VV-020
- Conditions
- Heart Failure (HF)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Aventusoft, LLC.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cleveland Clinic Florida
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Standard of Care | No intervention | –Standard of Care |
| Randomized Standard of Care with HEMOTAG | Active comparator | Diagnostic Test: Standard of Care with HemotagStandard of Care with HEMOTAG |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care with HemotagAlso: Standard of CareComparison of outcomes | Diagnostic test | Randomized Standard of Care with HEMOTAG |
Primary outcome
The number of recurrent HF readmissions. [Monitoring period: 30 days]
Time frame: 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]
4 secondary outcomes
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 frame: 6 Months
Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months]
Time frame: 6 Months
Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]
Time frame: 6 Months
Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Snipelisky, MD principal investigator
Cleveland Clinic Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure (HF), run by Aventusoft, LLC. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Kober (561-945-9303, cindy@aventusoft.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of recurrent HF readmissions. [Monitoring period: 30 days] (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.