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
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
Treatments tested in this trial
- Standard of Care with Hemotag
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aventusoft, LLC.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Cleveland Clinic Florida
Collaborator
Source ClinicalTrials.gov