Actively Recruiting
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]
Led by Aventusoft, LLC. · Updated on 2024-08-21
420
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aventusoft, LLC.
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the HEMOTAG® system to help manage heart failure patients outside of traditional medical settings. The goal is to reduce hospital readmissions by testing, adapting, and validating this system for use by patients in their everyday environments. This study focuses on short-term outcomes for people with heart failure, assessing how well the system works in real-life situations compared to standard care. Participants are randomly assigned to one of two groups: standard care alone or standard care combined with the HEMOTAG® system. The study observes participants over 30 days for hospital readmission rates and monitors related outcomes up to six months. The HEMOTAG® system, considered a diagnostic test, is being assessed as an additional tool alongside usual treatments to evaluate its impact on heart failure management. During the study, participants will have their health monitored regularly, including tracking hospital readmissions due to heart failure and any skin irritation from using the HEMOTAG® device during the first 30 days. Researchers also measure time to readmission, total days lost to hospitalization, and all-cause mortality up to six months after discharge. The study includes assessments through medical records and patient monitoring to understand how the system affects short-term health outcomes and safety over the monitoring periods.
CONDITIONS
Brief Title
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 22 years old.
- Recent hospital admission for acute decompensated heart failure with symptoms, clinical signs, and chest x-ray showing pulmonary congestion.
- Receiving intravenous diuretics or vasoactive drugs during the hospital stay.
- BNP greater than 350 or NT-pro BNP greater than 1800 pg/ml.
- Able to give informed consent.
- Residence with adequate cellular data coverage.
- If diagnosed with left ventricular ejection fraction less than 40% before hospitalization, treated for at least 90 days with diuretics, beta-blockers (unless intolerant or contraindicated), and ACE inhibitors or ARB or ARNi (unless intolerant or contraindicated).
You will not qualify if you...
- Unable to provide informed, voluntary consent.
- Terminal condition with life expectancy under 6 months.
- Cardiac tamponade or constrictive pericarditis.
- Left ventricular assistance device (LVAD), cardiac transplantation, or listed for transplantation.
- Implantation or planned implantation of cardiac resynchronization therapy (CRT) device during hospitalization.
- Significant mitral or aortic valve disease (except mitral regurgitation from left ventricular dilatation).
- Significant obstructive lesions of left ventricular outflow tract.
- Severe primary lung, kidney, or liver disease.
- Women of childbearing age under 50 years.
- Pulmonary embolism within the last 3 months.
- Dialysis-dependent or expected to start dialysis within 3 months.
- Chronic home intravenous therapy or cardiac inotropes or diuretics.
- Chest deformity or lesion preventing proper HEMOTAG application.
- Skin conditions causing intolerance to the HEMOTAG electrodes.
- Impaired cognitive ability or inability to comply with the study.
- Complex or uncorrected congenital heart disease.
- Enrolled in another interventional study.
- Heart failure managed remotely with certain monitoring devices or programs.
- Prisoners or wards of the state.
- Inability to provide informed consent in English, Spanish, or Creole.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months from discharge
Participants are monitored to assess heart failure readmissions and related outcomes over time.
Visits at 30 days, 3 months, and 6 months
Trial Site Locations
Total: 2 locations
1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
2
Baylor Scott & White Research Institute
Temple, Texas, United States, 76508
Actively Recruiting
Research Team
C
Cindy Kober
K
Kaustubh Kale
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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