NCT04149743 · Aventusoft, LLC.
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
(HATS-OFF)
What this study is about
Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.
View original scientific description
Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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.
- 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).
Where
- Weston, Florida
- Temple, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2024 · Source of record for eligibility and locations