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About
Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations.
Although functional status can be objectively measured by peak exercise oxygen consumption, it is difficult and impractical to implement in large clinical studies, especially in an ambulatory real-world setting. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms.
The goal of this observational study is to evaluate the feasibility of monitoring functional capacity among patients with heart failure (HF) using mobile health monitoring platforms.
Everion® and Apple Watch Series 4 and above will be used for this study. The BiovitalsHF® mobile app can capture patients' key cardiopulmonary physiological parameters, functional capacity (using activity patterns, including guided mobile-based 6MWT, audio recording) and assessment of QoL through validated PROs.
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Inclusion and exclusion criteria
Inclusion Criteria:
Subjects are eligible to be included in the study only if all the following criteria apply:
Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
Disease Related
Other Medical Conditions
Prior/Concomitant Medication
Other Exclusions
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Data sourced from clinicaltrials.gov
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