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Dr. Weber:
Hello. There's been a lot of interest lately in the FINEARTS study and we're going to be talking a little bit about that. And I'm particularly delighted that my colleague Dr. Peter Rossing is here since he has been very much connected with that important study, looking at the relationship between heart disease and chronic kidney disease and how we might learn from this study how to better manage our patients with chronic kidney disease who are so much at risk of cardiovascular outcomes.  

This is CME on REACHMD. I'm Dr. Michael Weber. I'm at the Downstate University of the Health Sciences in New York. And, Peter, over to you. 

Dr. Rossing:
I'm Peter Rossing and I'm at Steno Diabetes Center at Copenhagen, and it's a great pleasure to be here and to discuss FINEARTS with all of you.  

My experience with the nonsteroidal mineralocorticoid receptor antagonist finerenone has started with type 2 diabetes and kidney disease in the FIGARO and FIDELIO trials. But FINEARTS is the first trial testing finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in people with heart failure with an ejection fraction above 40, so you can say what is called heart failure with preserved ejection fraction or mid-range ejection fraction, a population where we have very limited opportunities for treatment today because only SGLT2 inhibitors have demonstrated benefit in clinical trials in this population. So although we are realizing that this is a large and growing population, we have actually not very good tools to handle this high-risk population. So therefore, a new trial is very much needed. 

And FINEARTS-HF is a trial where more than 6,000 patients with heart failure with preserved ejection fraction or ejection fraction above 40 have been randomized to this nonsteroidal mineralocorticoid receptor antagonist, finerenone, or placebo. And the trial is fully recruited and is just concluded. The results will be presented later this year.  

And the baseline data or baseline population that was included in the trial is quite typical for these trials in heart failure with preserved ejection fraction in the sense that it's a population of elderly people with ejection fraction around close to 50. It's also a population where a high percentage has a cardiovascular disease or has diabetes, so 40% have a history of diabetes. And in this population, the endpoint of the trial, that will be hospitalization for heart failure or acute heart failure events or cardiovascular mortality, and of course also symptoms related to failure or the components of heart failure are being evaluated and also other cardiovascular events are being looked into as well as all-cause mortality. 

So it's really exciting because in the past there was other trials with the steroidal mineralocortocoid  receptor antagonists, which suggested that there might be a benefit but also some doubt in this population in contrast to the studies done in heart failure with reduced ejection fraction where we have much more opportunities for intervention today. So I think FINEARTS is a long-awaited trial and it's really going to be exciting to see how the trial reads out because, as I mentioned, we really don't have many opportunities. SGLT2 inhibitors were recently established, but otherwise we actually haven't seen anything. And this is despite factors in our cases like diabetes, hypertension, obesity at very high risk for having this condition of heart failure, which has a quite significant prognosis. And I think there has been a focus among us and cardiologists are focusing on the heart failure with reduced ejection fraction, and we have really failed to find treatments and to follow carefully this other population. 

So it's really going to be interesting to see if the nonsteroidal mineralocorticoid receptor antagonist finerenone can provide additional benefit in this population. You can say based on the learnings from the FIGARO and FIDELIO, the type 2 diabetes CKD trials, we could expect the hope for something good in the sense that in these trials there was a reduction in new-onset heart failure and also a reduction in events of hospitalization for heart failure, which was a quite important driver of the cardiovascular benefit in that trial, which also showed benefit on kidney disease progression. So it's certainly going to be interesting to learn the results of FINEARTS. 

Importantly, the FINEARTS trial will not only include the primary outcome of cardiovascular death and worsening heart failure events, but also look into the components and look into symptoms such as anxiety and dyspnea related to heart failure, which is being evaluated by the KCCQ [Kansas City Cardiomyopathy Questionnaire] questionnaire developed for heart failure evaluation. 

Dr. Weber:   
Well, thank you, Peter, and I think all of us, whether we are in primary care practice, whether we're cardiology oriented or kidney people, you've pointed out the close interconnection between all of these outcomes, and particularly the fact that we have not had available to us reliable or predictably reliable treatments for people with heart failure with preserved ejection fraction, people with ejection fractions above 40. And this will certainly be addressed in the FINEARTS study. Right now, some of us believe that the mineralocorticoidreceptor antagonists do have a part to play in patients with this kind of heart failure. Some of the other treatments, other than diuretics, of course, not that well established, maybe the SGLT2 agents for people who have some of the forms of heart failure with preserved ejection fraction. So this will be very important information coming from FINEARTS both for the kidney and for the heart, and perhaps it'll be the incentive for all of us now to be able to tie together heart disease and progressive kidney disease.  

Peter, thank you so much for giving us this terrifically important background, and I'd like to thank all of you who have joined us for this discussion. 

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