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

Project Start: September 2018

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.