Janssen Launches First Fully Virtual Clinical Trial to Expand Canagliflozin’s Use in Heart Failure

Recently, Janssen, a subsidiary of Johnson & Johnson, announced the launch of the first fully “virtual” clinical trial. The trial will use participants’ personal smartphones and wearable devices to monitor patients, eliminating the need for them to visit clinical sites in person for examinations. Named CHIEF-IHF, this clinical trial aims to collect real-world evidence to support a new cardiovascular indication for the company’s SGLT2 inhibitor canagliflozin (brand name Invokana). It is expected to enroll approximately 1,900 adult patients with heart failure in the United States, who may or may not have type 2 diabetes. According to Janssen’s press release, this is the world’s first fully decentralized, mobile device-enabled “virtual” clinical trial seeking to expand indications.

Through collaboration with PRA Health Sciences, patients participating in clinical trials can report changes in quality of life via app-based clinical questionnaires. Meanwhile, researchers will collect patients’ daily activity data—including daily step counts and stairs climbed—through smartphone apps and wearable devices worn by the patients.

Canagliflozin is an SGLT2 inhibitor that has been approved to reduce the risk of stroke and cardiovascular death in patients with type 2 diabetes who have established cardiovascular disease. The aim of this clinical trial is to expand the use of canagliflozin to heart failure patients without type 2 diabetes. Various SGLT2 inhibitors have demonstrated promising efficacy in reducing major adverse cardiovascular events. Recently, AstraZeneca’s dapagliflozin has received Fast Track designation from the FDA for the treatment of heart failure patients.

References:

[1] Janssen Leverages Wearable Technology to Reimagine Clinical Trial Design. Retrieved November 17, 2019, from https://www.janssen.com/janssen-leverages-wearable-technology-reimagine-clinical-trial-design

[2] AHA: Janssen drops clinical sites for smartphones, wearables in 100% virtual Invokana study. Retrieved November 17, 2019, from https://www.fiercebiotech.com/medtech/aha-janssen-drops-clinical-sites-for-smartphones-wearables-100-virtual-invokana-study

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