Henry Ford Health lauds results of fully virtual heart failure study

The study, involving 476 patients recruited through 18 health systems, was conducted on a fully virtual platform, with researchers communicating and collecting data from patients through an mHealth app and online portal. It may serve as a model for future clinical trials.

Researchers at Henry Ford Health are celebrating the results of a multi-institutional heart failure trial that was conducted entirely on a virtual care platform, saying it could be the model for future clinical trials.

About 476 patients were enrolled in the study through 18 participating health systems between March 2020 and February 2021 – during the height of the pandemic, when every effort was made to reduce in-person treatments. Researchers connect with study participants through an mHealth app and online portal where they communicate with patients and collect data from surveys and Fitbit devices. The drugs used in the study were mailed to the participant’s home.

“What this study demonstrates is that you can do a virtual clinical trial more efficiently than a traditional, in-person trial,” David Lanphear, MD, an advanced heart failure specialist at Henry Ford Health and one of the eight authors of the study report, published recently in Nature Medicine, said in a press release. “This could lead to more people being enrolled in medical research because of the convenience of participating from home and the potential for lower costs and faster results.”

The study aimed to test the value of sodium-glucose co-transporter 2 inhibitor (SGLT2i), a newer class of drugs used in the treatment of heart failure and shown to improve clinical outcomes. It also looked at how these drugs can be administered to patients at home, how this can affect their quality of life, how patients can report their own data and observations through a connected health channel, and how patient-reported outcomes can affect of treatment and results.

“The costs of conducting clinical trials have risen significantly over time, leading to calls for new trial designs to generate the evidence needed to guide care,” Lanfear and colleagues said in the report. “A large component (up to 50%) of these costs is the data collection burden at sites, which has increased nearly fourfold from 1990 to 2010. The ongoing global pandemic of coronavirus disease 2019 (COVID-19) has further highlighted the challenges of traditional research designs that depend on in-person visits and resource-intensive data collection and verification. In response to increasing demands for clinical trials to become more pragmatic, new study designs have been introduced, from using existing registries for data collection to using of eHealth records to identify, enroll, randomize, and track eligible patients. Although the innovation of eliminating in-person visits in clinical trials has been proposed, to our knowledge it has not been tested on a large scale.

Lanfear and colleagues said the virtual trial may be “the first randomized drug trial of its kind in cardiology.” It can also set the bar for clinical trials by eliminating geographic barriers to patient recruitment, allowing healthcare organizations to find the right participants no matter where they live. The platform allows researchers to better understand how patients are affected at home and in their daily lives and routines, while collecting biometric and other data in real time.

“Improving symptom severity is one of our primary goals in the management of heart failure patients,” he said in the press release. “Clearly, this study showed that these agents have a meaningful impact on patients within just weeks of starting treatment, which we were able to demonstrate using a virtual research approach.”

The platform also lowers barriers to patient engagement. Lanfear noted that enrollment in this study was approximately five times faster than in traditional in-person heart failure clinical trials.

Erik Wiklund is the innovation and technology editor for HealthLeaders.

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