University Health Network, Toronto announced the launch of a new clinical study to check the efficacy of the Apple Watch as it pertains to conducting a CPET (Cardiopulmonary exercise test) for evaluating heart failure risks.
Details of the new clinical trial/study were posted today on NIH’s ClinicalTrial site.
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Heart Failure (HF) is a complex disease associated with the highest burden of cost to the healthcare system.
According to CDC,
- About 6.2 million adults in the United States have heart failure.1
- In 2018, heart failure was mentioned on 379,800 death certificates (13.4%).1
- Heart failure costs the nation an estimated $30.7 billion in 2012.2 This total includes the cost of health care services, medicines to treat heart failure, and missed days of work.
The cardiopulmonary exercise test (CPET) is instrumental in determining the prognosis of patients with HF.
This study will evaluate whether aggregate biometric data from the Apple Watch combined with demographic, cardiac, and biomarker testing can improve our ability to predict heart failure outcomes among a diverse ambulatory HF population.
The study is designed to measure predictive power of Apple Watch metrics such as heart rate, ECG, oxygen saturation, estimated VO2 against CPET parameters such as peak VO2; VE/VCO2; Heart rate recovery; maximal heart rate; oxygen saturation and oxygen pulse.
It will also explore the accuracy of Apple’s mobility metric based 6MWT (Six minute walking test).
Secondary outcome measures as defined in this study are the following:
- Evaluate Apple Watch sensors and markers for poor prognosis. This will primarily explore the correlation between novel biosensors, including oxygen saturation, and markers of poor prognosis specifically as defined by the Seattle Heart Failure Model (SHFM), BNP, Quality of life (QOL) and CPET parameters
- Identify whether Apple Watch sensors in aggregate including step count; accelerometry; peak VO2; heart rate; ECG predict a composite outcome of unscheduled visits (including: rapid clinic visits, need for IV diuretics, ED visit and HF hospitalization)
- Identify novel biomarkers (eg. STS2, cell-free DNA, peripheral markers of the microbiome) collected by the biobank and digital signatures assessed by the Apple Watch (eg. behaviors, exercise, medication adherence) that predict a composite outcome of mortality, advanced heart failure therapies and hospitalizations
The study is expected to enroll 200 participants and is expected to be complete by March 2022.