Day 3 AHA: The Health eHeart Study: A Digital Disruption of Clinical Research

John Mandrola


November 18, 2014

In the plenary session at the American Heart Association (AHA) 2014 Scientific Sessions, Dr Elliot Antman (Harvard University, Boston, MA) held up a smartphone and compared it to a modern-day Swiss Army knife. He may be correct. A recent poll found that 91% of smartphone owners are within 3 feet of their devices the majority of the time. And any follower of the news knows we are on the leading edge of a revolution of body sensors.

Dr Jeff Olgin (University of California, San Francisco [UCSF]) is an electrophysiologist and chair of cardiology at UCSF. Along with group of researchers and Silicon Valley engineers, Olgin aims to harness the digital revolution to transform the way research is done in the future and, in the process, improve public health. I realize that is a lofty sentence. More simply, then, it's easiest to think of the Health eHeart study as a modern-day Framingham study.

What caught my attention about this effort came when Olgin, whom I knew from our IU days, told me they want to predict MI and sudden death. Think about that for a moment. Isn't that everything—the holy grail of cardiology? The simple fact remains from my training days: too many people discover they have heart disease with their first event. They were seemingly fine and then they are dead.

Go easy on me. Of course this stuff is a bit dreamy, especially at a meeting where the buzz is about a medicine—ezetimibe—that delivers marginally incremental, if any, benefits for patients who have already had an event. But put yourself in the minds of doctors before they had Framingham data. We take our current knowledge of the progression of heart disease for granted. For instance, when we treat atrial fibrillation now, we do so with the knowledge that Framingham data showed the disease increases the risk of death and stroke over decades.

The longitudinal Massachusetts study taught us a lot, but it did it with bricks and mortar. Health eHeart plans to follow and study people digitally. That's huge. Dr. Olgin told me they have already enrolled 14 600 patients from 32 countries. His goal is to have a million patients.

Imagine a million patients connected to sensors, which will soon monitor much more than pulse, blood pressure, and weight. Olgin said they will soon have sensors that monitor beat-to-beat heart-rate variability and sympathetic tone. They already use mobile ECGs. During these sessions, this group presented a study in which they validated a smartphone-based 6-minute-walk test.[1] The app, which allows patients with either pulmonary hypertension or heart failure to test their functional capacity at home, correlated well with traditional testing.

Of course, the most important vital sign to monitor, according to Dr Carl (Chip) Lavie (Oschner Clinic, New Orleans), is physical activity and fitness. Health eHeart plans to be interactive. Here you can see the benefits of monitoring physical activity and perhaps providing e-nudges—then measuring the effects of one type of e-nudge over another. The electric shock to get a couch potato up and moving might be most effective. (I'm kidding.)

Although predicting plaque rupture is a few years away, Health eHeart may also provide us something more immediate: a new way of doing clinical research. The notion is to harness the power of Big Data to answer important clinical questions.

My simple view of Big Data in medicine is this: what if you knew what happened to every patient you put on drug X? Then you would know a lot. Dr Ben Goldacre has talked about the idea of embedding clinical research electronically into clinical practice. Why not use the data?

Compare this method of research to the randomized clinical trial (RCT) of today. The big costs and long duration of doing an RCT means they are getting done either for major public matters or when industry sees something in it for them. We have many more questions in medicine than we have RCTs.

In the convention hall, I had a quick conversation with electrophysiologist and principal investigator of CABANA, Dr Doug Packer (Mayo Clinic, Rochester, MN). He said it's harder than ever to get funding for clinical trials. I was recently involved with getting a clinical trial started in athletes with AF. So far, we have not been able to get funding—and the principal investigator is from Yale.

I may be wrong about this enthusiasm for digital research, but I doubt it. Five to 10 years from now, look for important clinical data to come from studies like Health eHeart.



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