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  1. Advancing Regulatory Science

Evaluating mobile health tool use for capturing patient-centered outcome measures in heart failure patients

CERSI Collaborators: Christopher J. McLeod, MD, ChB, PhD (Mayo Clinic) (PI); Erica Spatz, MD (Yale); Curtis Storlie, PhD (Mayo Clinic); Joseph Ross, MD, MHS (Yale) (Site-PI); Molly, Jeffery, PhD (Mayo Clinic) (Site-PI); Charles J. Bruce, MBChB (Mayo Clinic)

FDA Collaborators: Mona Fiuzat, PharmD; Elizabeth Kunkoski, MS; Leonard Sacks, MD, Norman Stockbridge, MD, PhD; Robert Temple, MD; Ryan Robinson, MD

CERSI In-Kind Collaborators: Kuldeep Singh Rajput; Trace Brookins; Rachel Chan; Carolyn Lam; Felis Dwiyasa, PhD; Sandi Wibowo, PhD; Chen Hao, PhD; Maulik Majmudar, MD; Sylvia Ong; Kaixiang Chong; Jackie Velarde; Rachel Chan; Jaydev Thakkar   

Project Start: September 2018

Project Award Date: June 2025 

Regulatory Science Challenge

Heart failure (HF) is a common disease that also carries high morbidity and mortality. Reduction of HF mortality and hospitalization is the gold standard outcome of HF drug therapy. However, it is difficult to view mortality and hospitalization as the only patient outcomes of interest due to the length of time it takes to reach these measures. Additionally, patients with HF have substantially reduced functional capacity and quality of life. Considering these issues, there is a need to look for different patient outcomes, such has how a patient feels or functions daily, for HF drug therapies.

Project Description and Goals

The goal of this project is to test the feasibility of obtaining reliable measures of functional capacity and quality of life using everyday smartphones and wearable monitors (mobile health platforms) that can continuously record physiological characteristics that are important in HF. This study will inform the use of these measures as alternative trial endpoints for HF. HF patients will be recruited post-discharge from National Heart Centre and National University Hospital in Singapore and Mayo Clinic. Patients will be monitored at home using Bluetooth-connected wearable devices for a period of 60 days.

Goal 1: Determine the feasibility of using the mobile health platforms in heart failure patients to measure functionality and symptoms.

Goal 2: Determine the feasibility of using the mobile health platforms in heart failure patients to measure continuous activity levels and quality of life measures.

Upon completion, the data generated will help to establish whether these new digital measures are of value in evaluating new therapies for heart failure.

Research Results 

In this pilot study we found that it is feasible to use mobile health monitoring platforms to monitor the functional capacity of HF patients. In particular, the study reveals that certain accelerometer/physiological features, as well as voice and ECG parameters, have strong or moderate correlations with functional capacity, quality of life, and clinical outcomes.  In conclusion this demonstrates that mobile health monitoring in conjunction with advanced data analytics can be utilized to monitor functional capacity of patients with heart failure. Ambulatory physiological features and voice correlated with functional capacity, quality of life, and clinical outcomes – and deserve further scientific exploration. 

Research Outcomes  

Research Outcome 1 ​IV. Inform Regulatory Decision Making​: Wearable devices showcased significant promise for monitoring heart failure patients.  

Of the 65 HF patients initially enrolled, 59 (average age 56.7, SD 11.7; 83.1% males; NYHA classifications: 14 I, 36 II, 9 III) were retained for analysis after being screened post-clinic visits or hospitalizations due to HF. Physiological data, such as activity, nighttime respiration rates and resting HRV scores, showed noteworthy correlations with traditional patient outcomes. Distinctively, the study identified specific physiological metrics, such as elevated baseline heart rates and low Passive 6MWT step counts, as potential indicators for clinical deteriorations, such as hospitalizations or significant increases in NT-proBNP levels.

Research Outcome 2 ​II. Disseminate Scientific Knowledge​: Passive 6MWT emerging as a viable alternative to traditional functional assessments

The study revealed that Passive 6MWT distance, an indicator of peak daily distance, displayed a strong correlation with traditional investigator-guided 6WMD (r = 0.78, p-value < 0.001) and a moderate link with KCCQ-12 (r = 0.45, p-value < 0.01).  

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