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Diagnostic Test

Hemotag Monitoring System for Heart Failure (HATS-OFF Trial)

N/A
Recruiting
Led By Robert D Chait, MD
Research Sponsored by Aventusoft, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Participants with cardiac tamponade or constrictive pericarditis
Participants with left ventricular assistance device (LVAD device) or had a cardiac transplantation or listed for transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new system to help heart failure patients, by monitoring their blood and improving their care.

Who is the study for?
Adults aged 22 or older with acute decompensated heart failure (ADHF), high levels of BNP or NT-proBNP, and previous treatment for reduced heart function can join. They must live where there's good cell service, speak English/Spanish/Creole, and consent to participate. Excluded are those with life expectancy under 6 months, certain heart conditions, recent pulmonary embolism, dialysis patients, chest deformities that affect device use, cognitive impairments preventing protocol adherence.
What is being tested?
The trial is testing the HEMOTAG® system alongside standard care in people with heart failure. It aims to see how well the system works outside of a tightly controlled setting and prepare it for patient self-use at home.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort or skin issues from wearing the HEMOTAG device. The study will monitor any adverse reactions related to the device's application and usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 22 years old or older.
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I was hospitalized for heart failure, needed strong medications, and had high heart stress levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart condition involving fluid or tightness around my heart.
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I have a heart pump or have had a heart transplant.
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I am getting or planning to get a heart pacing device.
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I have no chest deformities that would interfere with medical device placement.
Select...
I have a complex or untreated heart defect from birth.
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I am on dialysis or expect to start within three months.
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I am a woman under 50 years old.
Select...
I use chronic IV therapy or heart medication at home.
Select...
I can provide informed consent and speak English, Spanish, or Creole.
Select...
I have a serious blockage in the heart's outflow tract.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of recurrent HF readmissions. [Monitoring period: 30 days]
Secondary study objectives
Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 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.)
Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Randomized Standard of Care with HEMOTAGActive Control1 Intervention
Standard of Care with HEMOTAG
Group II: Randomized Standard of CareActive Control1 Intervention
Standard of Care

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,936 Previous Clinical Trials
47,792,233 Total Patients Enrolled
209 Trials studying Heart Failure
677,299 Patients Enrolled for Heart Failure
Aventusoft, LLC.Lead Sponsor
1 Previous Clinical Trials
189 Total Patients Enrolled
Cleveland Clinic FloridaOTHER
13 Previous Clinical Trials
4,016 Total Patients Enrolled
1 Trials studying Heart Failure
230 Patients Enrolled for Heart Failure

Media Library

Hemotag (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04149743 — N/A
Heart Failure Research Study Groups: Randomized Standard of Care with HEMOTAG, Randomized Standard of Care
Heart Failure Clinical Trial 2023: Hemotag Highlights & Side Effects. Trial Name: NCT04149743 — N/A
Hemotag (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04149743 — N/A
~0 spots leftby Dec 2024
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