An observational study in Heart Failure, sponsored by Biofourmis Singapore Pte Ltd.. Terminated at 6 sites in 2 countries. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Biofourmis Singapore Pte Ltd. · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 67 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Biofourmis Singapore Pte Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 150 eligible subjects will be enrolled into the study. Eligible subjects will include adults with a diagnosis of heart failure (NYHA class I to class III), and screened within 30 days after Clinic Visit or hospitalization for heart failure - either as a primary or secondary diagnosis.
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
Feasibility of monitoring functional capacity among patients using mobile health monitoring platform
Measurement of correlation between physiology and accelerometer (activity) data/derivatives with: * 6MWT * Patient-reported KCCQ * Lab results
Time frame: 8 weeks
Compliance rate
Compliance rate to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform
Time frame: 8 weeks
Drop-out rate
Drop-out rate to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform
Time frame: 8 weeks
Mean time worn/day
Mean time worn/day to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform
Time frame: 8 weeks
Proportion of time worn that device produces reliable data
Proportion of time worn that device produces reliable data to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform
Time frame: 8 weeks
Percentage of patients on HF GDMT
Percentage of patients on beta blocker, ACE/ARN/ or ARNI and MRA
Time frame: 8 weeks
Percentage of patients on target dose of HF GDMT
Target dose of HF GDMT is according to 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment
Time frame: 8 weeks
Unplanned hospital visits of patients on HF GDMT and target dose of GDMT
30-days hospitalization, Clinic visits and ED visits, and its correlation to patients on HF GDMT and target dose of GDMT
Time frame: 8 weeks
Questionnaire for patient experience
Questionnaire to evaluate the subjects' experience with the mobile device(s) and mobile health monitoring platform
Time frame: 8 weeks
Association of ECG/Vitals/voice-related biomarker to progression of HF disease
Ability to detect changes in ECG/Vitals/voice biomarker, and correlate with functional status and clinical outcomes
Time frame: 8 weeks
Plan to share: No
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Biofourmis Singapore Pte Ltd.