A Plan to Chart Heart Risk in 1 Million Adults in Real Time

Ron Winslow, The Wall Street Journal

Researchers are launching a major study that will marshal the power of smartphones and other personal technologies in an effort to develop new strategies for preventing and managing heart disease.

The project, called the Health eHeart Study, will use tools such as smartphone apps, sensors and other devices to gather data on a wide variety of measures associated with cardiovascular health—including blood pressure, physical activity, diet and sleep habits—all in real time.

The study aims to enroll up to one million participants. Researchers will sift through the huge, accumulating banks of data, looking for patterns that might give advance warning of a heart attack or predict the onset of a dangerous irregular heart beat.

The initiative amounts to “a large-scale digital version of the Framingham Heart Study,” said Jeffrey Olgin, chief of cardiology at University of California, San Francisco and co-principal investigator of the effort. The continuing 65-year-old Framingham study is one of the most influential research endeavors in medical history.

The project also reflects burgeoning interest in the potential of smartphones to transform health care by reducing doctor visits and empowering patients to monitor their own health and track their compliance with good diet and exercise habits. But how smartphones and other mobile devices may actually affect people’s health isn’t known.

This technology “is going to change dramatically the way we deliver health care,” Dr. Olgin said. “We want to be sure it’s being evaluated in a scientifically appropriate way.”

Framingham is the longest-running study of the causes of cardiovascular disease. The federally funded program identified smoking, high blood pressure, high cholesterol and diabetes as major risk factors for heart ailments. A calculation derived from its findings predicts a person’s 10-year risk of a heart attack, which doctors commonly use to guide prevention strategies for patients.

The study is credited with playing a major role in the greater-than-50% decline in the death rate from cardiovascular disease in the U.S. in the last half-century.

Heidi Dohse, with her trainer, Bill Kemmerer, trains in Whitehouse Station, N.J. She is an early volunteer for the Health eHeart Study.

But data in Framingham are collected only once every two years—during the participants’ biennial checkups. The 10-year risk score can’t predict exactly who might have a heart attack next week or next year. And it remains unknown why many people with seemingly low risk end up with a heart attack or stroke while some who smoke, eat poorly or get little exercise live into their 80s.

Dr. Olgin and co-leaders Greg Marcus, a cardiologist, and Mark Pletcher, an epidemiologist, both also at UCSF, believe that Health eHeart can fill in some of the gaps. They hope to develop more precise strategies to predict development of heart disease in people who don’t yet have it and slow its progression among those who do.

Among tools available or in development are GPS-enabled phones that can record whether a person is at a fast-food restaurant, shopping at a farmer’s market or bedridden in a hospital, and a photo app that can estimate meal portion size and calorie content.

The study, funded so far by private philanthropy, can collect almost all of its participants’ data without the need to see a doctor. People can even sign up for the study online without a doctor visit, almost unheard of in clinical research.

“It’s very nimble and very inexpensive,” Dr. Olgin said.

Dr. Jeffrey Olgin, a doctor at University of California, San Francisco and co-principal investigator of Health eHeart.

Instead of examining blood pressure every year or two, participants can record that measure in 30 seconds several times a day with a Bluetooth-enabled blood pressure cuff that sends readings instantly via smartphone to the study database.

Why so many? Doctors believe answers to many questions about high blood pressure lie in rarely measured intervals between checkups. One little-understood problem: the patient whose blood pressure is normal at rest, but spikes right after exercise.

By collecting blood pressure data from such people at various times and during different activities, researchers hope long-term follow-up will reveal whether they are at high risk for heart trouble, and what interventions might reduce the risk.

Heidi Dohse says the study is helping her take more charge of her care. Ms. Dohse, a 49-year-old executive at Google Inc. in New York, underwent treatment for a congenital heart defect discovered when she was 18. It left her dependent on a pacemaker to keep her heart beating.

Why Framingham Matters

Key facts about the Framingham Heart Study, considered one of the most influential research endeavors in the history of medicine and an influence on the new Health eHeart Study.

  • The study began in 1948 by enrolling 5,209 residents of Framingham, Mass., with a series of physical examinations and lifestyle interviews for as long as they lived.
  • It is how we know smoking, high cholesterol and high blood pressure are major risk factors for heart disease and informs how doctors estimate their patients’ long-term risk of a heart attack.
  • Administrators enrolled a second generation of participants, the original subjects’ adult children and their spouses, in 1971. More people joined in 1994, 2002 and 2003, including new participants from more diverse backgrounds.
  • The multigenerational nature of the study has allowed doctors to better investigate the role of genetics in cardiovascular disease.
  • The study has led to the publication of approximately 1,200 articles in major medical journals.

Source: Framingham Heart Study

She had a 10-year-old pacemaker replaced a few weeks ago. It gave her “a new set of heartbeats” that initially felt strange during her cycling workouts, she said. But the feedback from her AliveCor device, a sensor that clips to the back of an iPhone and allows patients to take their own electrocardiograms, checked out normal, providing reassurance.

“Instead of waiting for my doctor to determine when I need care, I feel like it makes me more accountable,” she said.

Researchers hope her data will help yield new information about people who rely on devices like hers.

The doctors behind Health eHeart also hope to help solve the riddle of what causes atrial fibrillation, an irregular heartbeat that can lead to stroke and now affects more than three million Americans.

David Dye, 65 years old and an avid cyclist, snowboarder and windsurfer who has been battling the condition for 15 years, was the first person to sign up for the study. A recently retired physicist in California, Mr. Dye already owned an AliveCor device. “If I get more data, I can figure out what my triggers are,” he said.

The study faces big challenges, among them how to find insights in all the data that will stream in from participants around the U.S. Dr. Olgin said his research team is working on algorithms to help handle the task.

Another concern is that the quality of the data won’t be as robust as that gathered during in-person doctor visits. Researchers hope the sheer volume of participants will wash out the effect of bad data. The study isn’t providing smartphones to participants, so people who can’t afford them won’t be well-represented.

Meantime, leaders of the Framingham study say they are intrigued by digital’s potential role in heart research. “No doubt there’s enormous promise here for new technology to change our understanding of health and disease,” said Daniel Levy, who leads the Framingham study.

But Dr. Levy, who isn’t familiar with the UCSF plans, said Framingham researchers want more information about how such techniques would affect privacy and other issues before including them as study tools.

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