Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    150
  • sponsor
    Biofourmis Singapore Pte Ltd.
Updated on 4 June 2022
heart failure
diuretics

Summary

The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis.

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. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies.

In this study, the investigators will test the feasibility of a novel mobile health monitoring platform to capture patients' physiology, functional capacity and assessment of quality of life.

Description

Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. Improvements in mortality and healthcare utilization, including hospitalizations of HF still remain the gold standard outcomes for HF drug approval. However, it is difficult to improve mortality as the only endpoint due to the variation in the age groups and comorbidities of the population and ineffectiveness to alter all-cause mortality, particularly in patients with heart failure with preserved ejection fraction (HFpEF). Considering these issues, there is a need for exploration of complimentary endpoints. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis. 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. Other objective measures of functional status include a 6-minute walk test (6MWT) and potentially measures of activity using implanted or wearable sensors. Patient-reported outcomes (PROMs) can also be used to record and quantify symptoms but are cumbersome and impractical since significant resources are required to contact patients and administer questionnaires. It is also particularly difficult to record these and correlate with physiologic signals in real-time.

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. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies. A novel mobile health platform (BiovitalsHF, developed by Biofourmis) enables continuous acquisition and monitoring of multiple physiologic data (for e.g. electrocardiogram, heart rate, respiration rate, activity intensity, 3-axis accelerometer and sleep) using readily available biosensors (Everion® MD and Apple Watch will be used for this study). The BiovitalsHF smartphone app is capable of capturing patient's physiology, functional capacity (using activity patterns, including guided mobile-based 6MWT) and assessment of QoL through validated PROs.

Details
Condition Heart Failure
Clinical Study IdentifierNCT04191356
SponsorBiofourmis Singapore Pte Ltd.
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
History of (within the past 6 months) or current use of diuretics
activities/procedures
Age more than 21 to less than 85 years at signing of informed consent
Diagnosis of heart failure, defined as requiring pharmacologic treatment for heart
failure, with NYHA class I to class III at most recent screening assessment
Screening within 30 days after Clinic Visit or hospitalization for heart failure -
either as a primary or secondary diagnosis
HF patient who is willing to comply with study restrictions including Everion device
management (wearing and charging the device), Apple watch Series 4 and above device
management (wearing and charging the device) and BiovitalsHF Patient App Management
(pairing Everion device and Apple watch Series 4 and above and BiovitalsHF Patient
App, and carrying the smartphone for answering questionnaires and data reporting)

Exclusion Criteria

Disease Related
Symptomatic bradycardia or second or third-degree heart block without a pacemaker
Other Medical Conditions
Prior/Concomitant Medication
Subjects are excluded from the study if any of the following criteria apply
Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation
Other Exclusions
myocardial infarction, unstable angina) stroke, or transient ischemic attack, major
cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 30
days prior to screening
Less than 4 months prior Interventional Clinical Study participation
Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) more than
or equal to 180 mm Hg or diastolic BP (DBP)more than or equal to 110 mm Hg
Untreated severe ventricular arrhythmia (e.g., ventricular tachycardia or ventricular
fibrillation)
Any individuals that are lacking the ability to consent
Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in
situ within the last 5 years
Hospitalization with any pathology that may meaningfully interfere with functional
tolerance, cardiopulmonary capacity or mobility within the 30 days prior to screening
Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or receiving dialysis
at screening
Currently receiving treatment or procedure in another investigational device or drug
study
Likely to receive during the duration of the study, in the opinion of the
investigator, planned revascularization, implantation of ICD or CRT, ventricular
assist device, continuous or intermittent inotropic therapy, hospice care, or cardiac
transplant
Implantable cardioverter defibrillator or initiation of cardiac resynchronization
therapy (CRT) (with/without implantable cardioverter defibrillator) within 30 days
prior to enrollment
Recipient of any major organ transplant (e.g. lung, liver, heart, bone marrow
kidney)
Subject likely to not be available to complete all protocol-required study visits or
procedures, and/or to comply with all required study procedures (e.g. Clinical Outcome
Assessments) to the best of the subject and investigator's knowledge
History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) that, in the opinion of the investigator
if consulted, would pose a risk to subject safety or interfere with the study
evaluation, procedures or completion
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