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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
HATS-OFF Trial 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.Check my eligibility
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.See study design
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.
HATS-OFF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Select...
I was hospitalized for heart failure, needed strong medications, and had high heart stress levels.
HATS-OFF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of recurrent HF readmissions. [Monitoring period: 30 days]
Secondary outcome measures
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 moreHATS-OFF 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
3,834 Previous Clinical Trials
47,310,215 Total Patients Enrolled
206 Trials studying Heart Failure
677,028 Patients Enrolled for Heart Failure
Aventusoft, LLC.Lead Sponsor
Cleveland Clinic FloridaOTHER
12 Previous Clinical Trials
3,962 Total Patients Enrolled
1 Trials studying Heart Failure
230 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious heart valve issues, not caused by heart enlargement.I have a complex or untreated heart defect from birth.I have a heart condition involving fluid or tightness around my heart.You have a serious illness and are not expected to live for more than 6 months, as determined by the doctor.I have a heart pump or have had a heart transplant.I was hospitalized for heart failure, needed strong medications, and had high heart stress levels.I have a serious blockage in the heart's outflow tract.I can make my own decisions about joining a study.You have a condition that may get worse or cause a lot of discomfort if you use the HEMOTAG device, such as skin problems or intolerance to skin electrodes.I have no chest deformities that would interfere with medical device placement.I am 22 years old or older.I am on dialysis or expect to start within three months.My heart failure is monitored using a device or program not part of another study.I am a woman under 50 years old.I use chronic IV therapy or heart medication at home.I had a lung clot less than 3 months ago.I can provide informed consent and speak English, Spanish, or Creole.I do not have severe lung, kidney, or liver disease.I have been treated for a heart condition with specific medications for at least 3 months.I am getting or planning to get a heart pacing device.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Standard of Care with HEMOTAG
- Group 2: Randomized Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots to participate in this trial at present?
"Affirmative. On clinicaltrials.gov, it is made obvious that this experiment has begun recruiting participants; the trial was posted on January 31st 2022 and subsequently modified on April 29th of the same year. This study requires 420 individuals to be recruited from one single site."
Answered by AI
What is the current intake capacity for participants in this trial?
"Indeed, this medical investigation is recruiting participants. According to the information on clinicaltrials.gov, which was last modified April 29th 2022 and first published January 31st 2022, 420 people are needed at a single location for completion of the trial."
Answered by AI
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