Two periods:
Run-In period will be a period in which patients will submit daily recordings, baseline creation
Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age 22 or greater
2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
3. At least one of the following:
1. One ADHF hospitalization in the last 12 months
2. One unplanned IV/SC diuretic administration in the last 6 months
3. Two unplanned IV/SC diuretic administrations in the last 12 months
4. NTProBNP \>500 pg/ml
4. Clinically stable HF according to investigator discretion
5. Willing to participate as evidenced by signing the written informed consent.
You may not be if
1. Unable to comply with daily use of the App,
2. Has had a major cardiovascular event within 3 months prior to enrolment.
3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
6. Was treated for a significant COPD
Clareo Health | AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
