New Clinical Trial for Heart Failure Tests Patients Remotely Using Wearable Devices

September 14, 2020
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Saint Luke’s Mid America Heart Institute is one of several large health care systems participating in a randomized national clinical trial called Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF).

The 2000-adult trial will study whether a medicine for type 2 diabetes called canagliflozin can improve quality of life in patients with heart failure. It will study patients with and without diabetes. This is the world’s first decentralized, digitally driven medical study where patients wear FitBits to record their daily step counts and activity that links to a smartphone app. Additionally, their progress is self-reported through the Kansas City Cardiomyopathy Questionnaire, an outcomes measure developed by the Mid America Heart Institute team that accurately measures symptoms, function, and quality of life.

“The trial is modeling a whole new approach to conducting clinical trials of new drugs – one that directly addresses the long-standing problem that most clinical trials are too slow and too expensive to conduct,” said Saint Luke’s cardiologist John Spertus, MD. “Accordingly, there aren’t enough clinical trials that have the evidence to define the benefits of new treatments. If successful, the CHIEF-HF trial will set a new standard for clinical research.”

Dr. Spertus says that collecting patient data through wearable devices is more convenient for patients because it doesn’t require them to travel to the study site, park, wait for the visit, and then go home. It enables them to contribute to science in a way that is more seamless with their everyday lives.

Cardiologist Mikhail Kosiborod, MD added, “Not only is Saint Luke’s an active participant in this trial, but our researchers have been intimately involved in the design of the study. We developed its primary outcome, will support some of the analyses, and have an unparalleled experience in how to design and conduct future virtual clinical trials.”

The trial was initiated at the beginning of the COVID-19 pandemic when many businesses and events were suspended or cancelled. But because the patient research is remote, it was still able to launch and enroll patients even when most other clinical trials had to pause.

“We can really determine how people function better using the data collected from their wearable devices,” said cardiologist Michael Nassif, MD. “We’ll know if they’re going out, going to the park, spending time with family, and more. I really think it will get to the core of what patients and physicians want to know. If it goes as well as we think it will, then it’s possible that digital medicine and diagnosing through wearable devices will become mainstream within the next few years.”

Learn more about Saint Luke’s Mid America Heart Institute – ranked #22 in the nation for Cardiology and Heart Surgery by U.S. News and World Report.

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