番茄社区

The SGLT2 inhibitor within 3 months, regardless of patients' ejection fraction or diabetes status, according to a study presented at the recent American Heart Association (AHA) virtual meeting.

In this exclusive 番茄社区 video, study author , of the University of Missouri-Kansas City School of Medicine, discusses the results of the fully remote CHIEF-HF trial, and the benefits of this unique approach.

Following is a transcript of his remarks:

I had the privilege of being the PI [principal investigator] of a study that Janssen supported called CHIEF. And, it was a randomized clinical trial to test whether or not canagliflozin, an SGLT-2 inhibitor, would improve the health status -- particularly the symptoms of heart failure in patients who had either HFrEF [heart failure with reduced ejection fraction] or HFpEF [heart failure with preserved ejection fraction] and who were randomized to placebo or canagliflozin. And we focused on 3 month total symptom scale of the Kansas City Cardiomyopathy Questionnaire (KCCQ), which is a self-administered questionnaire by patients to describe their symptoms, functioning quality of life.

What was really novel about CHIEF was that it was done without a single face-to-face visit. It was completely de-centralized. Sites did identify patients in their health system who had heart failure and who were not taking an SGLT-2 inhibitor, and then they invited them to participate in the trial. And patients would click onto a website to learn about the trial. If they were interested, a more thorough screening by the site investigators would occur. And then patients who were eligible would go to learn more about the trial to complete informed consent virtually, and then they would complete the KCCQ. And if their overall summary score was higher than 80, they weren't eligible. They weren't sick enough to really potentially benefit. But those whose scores were below 80 were then randomized. And if randomized, they would get a sort of mailed set of study drug. It could be placebo or active drug. They would get a Fitbit that they would link to the app. And then they would be followed for 3 months to see how they did on the drugs.

And what was really interesting was that the study was able to retain and get complete data on well over 90% of the patients. Over 95% of the patients took the study drug more than 80% of the time. And at the end of 3 months, we found an important statistically significant and clinically valuable improvement in the total symptom score. We actually were able to get the KCCQ at multiple time points, more than just the endpoints. We got it at 2, 4, 6 and 12 weeks. And, the curve separated within 2 weeks, which is really even to date since CHIEF was launched, other studies have come out -- the DAPA-HF, the EMPEROR-Preserved, EMPEROR-Reduced -- all showing an improvement in the KCCQ, but none of them had sort of this refined early assessment. And these curves separate within 2 weeks and it sustained out to 12 weeks.

And so to me, it's some of the most novel and unique data about how fast these drugs improve the health status of patients. And while there are other studies showing even longer benefits of therapy, patients when they take a new drug would like to feel better quickly. And this really supports that this medication does. And then it's really a unique trial because it launched 2 weeks before the national shutdown for COVID. It ended in the peak surge of Delta. And yet we were able to complete the entire trial, define the benefits of therapy.

And it was a very novel study design. It was at the time an important question that now has been confirmed in multiple other studies, because the benefits were available in those with and without diabetes, with HFrEF and HFpEF. And we have really modeled a new way of accelerating the course of conducting clinical trials and doing it in a way that's very, very patient-centered, not only in the outcomes, but also in the convenience of participation.

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