CHIEF-HF: Fully Remote Clinical Trial Shows Canagliflozin Improved HF Symptoms in Patients With/Without Diabetes
Canagliflozin significantly improved symptoms and quality of life within three months for individuals with heart failure due to either reduced or preserved ejection function, even if they didn't also have type 2 diabetes, according to findings from the CHIEF-HF trial presented Nov. 14 during AHA 2021. The trial was conducted completely virtual due to the COVID-19 pandemic and could be a model for future clinical trials.
Researchers enrolled 476 participants with a history of heart failure (median age of 63 years, approximately 45% female) from 18 health systems across the U.S. between March 2020 and February 2021. Of those enrolled, 285 had heart failure with preserved ejection fraction and a 133 had type 2 diabetes. Participants were randomized to receive 100 mg of canagliflozin (N=222) or placebo (N=226) and researchers measured symptom reports at two, four, six and 12 weeks. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was administered on a smart phone to determine whether canagliflozin improved symptoms in place of in-person visits.
Overall results found participants who received canagliflozin reported significantly greater improvements in their heart failure symptoms, starting within two weeks. These improvements were sustained throughout the entire three months of the trial. Additionally, researchers notes that participants with both reduced and preserved ejection fraction experienced improvements regardless of whether they had diabetes.
"These findings, together with the results of other SGLT2 inhibitor trials, are transformational and should have a significant impact on care," said John A. Spertus, MD, MPH, FACC, the study's lead author. "The impact of this class of medicines on patients' function and quality of life is larger than many other medications used to treat heart failure, and they are very safe. Since improvement in health status is such a key goal for many patients, these findings support increasing the use of SGLT2 inhibitors for people with heart failure."
In addition to the clinical findings, researchers said the fully virtual aspect of the trial and its ultimate success offer a new approach to clinical trials that could be used to test the effects of other cardiovascular therapies on quality of life and health status.
"We did not know if a completely 'virtual' clinical trial, especially one where randomized treatment was delivered to participants and the outcomes were collected through a smartphone app, could work," adds Spertus.
Keywords: AHA Annual Scientific Sessions, American Heart Association, AHA21, Quality of Life, Heart Failure
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