medwireNews: The virtual CHIEF-HF trial has demonstrated a significant positive effect of canagliflozin on heart failure (HF) symptoms without the need for in-person clinic visits, the investigators report in Nature Medicine.
The benefits occurred regardless of whether people had a reduced or preserved ejection fraction and whether or not they had diabetes, say John Spertus (Saint Luke’s Mid America Heart Institute/University of Missouri-Kansas City, USA) and co-researchers.
The study was designed to determine if sodium-glucose cotransporter 2 inhibition could improve HF symptom burden, which the team notes “is a critical goal for HF management.”
As this endpoint could be remotely reported by study participants completing the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a smart device, and the safety profile of canagliflozin is well established, CHIEF-HF was designed without in-person clinic visits.
The study authors note that it was “launched 2 weeks before a national shutdown due to the COVID-19 pandemic [which] highlights the potential advantages of a decentralized, virtual clinical trial.”
The intended patient enrollment for CHIEF-HF was 1900, but funding changes resulted in the trial closing early, leaving 448 participants in the intention-to-treat analysis.
However, Spertus and team suggest the original design “was arguably overpowered,” and indeed, they found a significant difference in the primary outcome between canagliflozin and placebo despite the smaller trial population.
During 12 weeks of treatment, the average KCCQ score in participants taking canagliflozin improved from 57.4 to 67.1.
The placebo group also registered an improvement, from 58.0 to 63.2 points. All trial participants had to report the number of doses of study medication taken via an app on a weekly basis, and the researchers suggest that this weekly reminder to take medication may have contributed to generally improved medication-taking and therefore improved scores in the placebo group.
However, the average 9.2-point improvement in KCCQ in the canagliflozin group was significantly greater than the 4.9-point change in the placebo group, and the difference between the groups began to appear as early as week 2, when scores had improved by 6.1 and 3.4, respectively.
The investigators say that organizing trial enrollment and outcomes data collection through a smartphone app “supported recruitment that was five times faster than the average enrollment rate in HF trials.”
But they also note the potential for selection biases caused by the need for trial participants to own and be able to use such technology.
Nevertheless, they conclude: “Such novel approaches to generating important evidence offer the potential for future clinical trials to lower the cost and increase the speed of acquiring new evidence to improve clinical practice.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group
Nat Med 2022; doi:10.1038/s41591-022-01703-8