Health TrialsbyHealthPanel

HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

ConditionHeart Failure (HF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorAventusoft, LLC.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care with Hemotag

    Diagnostic test

    Comparison of outcomes

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Randomized Standard of CareNo intervention 0 interventions
Group B: Randomized Standard of Care with HEMOTAGActive comparator 1 intervention

Trial outcomes

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. \[Monitoring period: 30 days from time of participant's discharge from initial index hospitalization\]

Time frame
30 Days

Secondary outcomes

1

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 \[Monitoring period: Event time assessed up to 3 months and 6 months from time of participant's discharge from initial study hospitalization.\]

Time frame
6 Months
2

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 frame
6 Months
3

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

Time from discharge to all-cause mortality \[Monitoring period: 30 days, 3 months,6 months from time of participant's discharge from initial study hospitalization.\]

Time frame
6 Months
4

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.)

Time frame
30 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aventusoft, LLC.

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Cleveland Clinic Florida

Collaborator

Source ClinicalTrials.gov
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