Andrew Sauer, MD, is a cardiologist and the codirector of Cardiovascular Research as well as the executive director of the Cardiometabolic Center Alliance at Saint Luke's Health System. 

Andrew Sauer, MD

Panelists discuss differentiating finerenone from steroidal MRAs in HFpEF

Differentiating Finerenone from Steroidal MRAs in HFpEF

, Stephen Greene, MD, Andrew Sauer, MD, and Muthiah Vaduganathan, MD, MPH, explored the comparative roles of finerenone (Kerendia), a nonsteroidal mineralocorticoid receptor antagonist (nsMRA) and steroidal mineralocorticoid receptor antagonists (MRAs), such as spironolactone, in the management of 

 with mildly reduced ejection or preserved fraction (HFmrEF/HFpEF).

Sauer opened the discussion by acknowledging the foundational role of steroidal MRAs in heart failure, noting the survival benefits shown in trials like RALES. However, he emphasized the evidence supporting finerenone in HFpEF, particularly from the FINEARTS-HF trial and earlier kidney disease-focused studies, marks a significant shift in the field. Finerenone demonstrated cardiovascular and kidney protection across a broad population with cardio-kidney-metabolic disease, which was not shown definitively with spironolactone in the same context.

Both Sauer and Vaduganathan highlighted the limitations of the TOPCAT trial, which informed existing but cautious guideline support for spironolactone in HFpEF. Sauer notes differences in study quality, regional variations, and underdosing within TOPCAT left many clinicians uncertain about the applicability of its results. In contrast, the consistent benefits observed with finerenone, including a favorable safety profile, present a stronger case for use in current practice.

The panel also discussed key safety considerations. Highlighting finerenone showed a lower incidence of hypokalemia in clinical trials and a potentially more favorable risk-benefit balance compared to spironolactone, particularly in patients on diuretics or with CKD.

, is an advanced heart failure specialist and an associate professor in the Division of Cardiology at Duke Clinical Research Institute. Greene serves as moderator for this discussion.

 is a cardiologist and the codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women's Hospital. Vaduganathan also served as an investigator on the pivotal FINEARTS-HF trial. 

, is a cardiologist and the codirector of Cardiovascular Research as well as the executive director of the Cardiometabolic Center Alliance at Saint Luke's Health System. 

 include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others. Relevant disclosures for 

 include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for 

 include Boston Scientific, Medtronic, Abbott, Impulse Dynamics, Amgen Inc., Biotronik, General Prognostics, Acorai, Bayer Healthcare Pharmaceuticals, CSL Vifor, and others.

Bayer. U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review. Bayer. Published July 14, 2025. Accessed July 14, 2025. 

https://bayer2019tf.q4web.com/news/news-details/2025/U-S--FDA-Approves-KERENDIA-finerenone-to-Treat-Patients-With-Heart-Failure-With-Left-Ventricular-Ejection-Fraction-40-Following-Priority-Review/default.aspx

Solomon SD, John J.V. McMurray, Muthiah Vaduganathan, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. 

Videos

Panelists discuss differentiators between nsMRA and steroidal MRAs in the context of heart failure.

Panelists discuss how approval of finerenone influences conversations on combination therapy. 

Finerenone and the Role of Combination Therapy in HFmrEF/HFpEF

 with mildly reduced or preserved ejection fraction in hand and backed by the phase 3 FINEARTS-HF trial, finerenone (Kerendia) could soon become a pillar of therapy for this patient population alongside the SGLT2 inhibitor class. 

, Stephen Greene, MD, Muthiah Vaduganathan, MD, MPH, and Andrew Sauer, MD, reflect on the prospect of combination therapy using finerenone. Vaduganathan offers an overview of the CONFIDENCE trial—a randomized study examining combination therapy with finerenone and empagliflozin in patients with type 2 diabetes and chronic kidney disease (CKD). 

CONFIDENCE enrolled 800 patients with type 2 diabetes and albuminuric CKD, randomized into three arms: finerenone alone, empagliflozin alone, and a combination of both. The primary endpoint was a reduction in urine albumin-to-creatinine ratio (UACR) over 180 days. Results indicated the reduction in the UACR with combination therapy was 29% greater than that with finerenone alone (least-squares mean ratio of the difference in the change from baseline, 0.71; 95% confidence interval [CI], 0.61 to 0.82; 

<.001) and 32% greater than that with empagliflozin alone (least-squares mean ratio of the difference in the change from baseline, 0.68; 95% CI, 0.59 to 0.79; 

As Vaduganathan points out, the benefits of combination therapy emerged early in the trial, were sustained, and attenuated upon therapy withdrawal in a post-treatment observation period. This durability signal reinforced a key message: clinical benefit depends on consistent treatment adherence. Vaduganathan underlined these data indicate therapies for progressive cardiorenal conditions only work when taken continuously—emphasizing the need for ongoing patient engagement and persistence.

Before closing, Greene concluded that data from CONFIDENCE offer important lessons for heart failure care: initiating multiple, complementary therapies early rather than slowly sequencing over time may yield better outcomes and reduce the risk of preventable hospitalizations and deaths in patients with preserved ejection fraction and related conditions.

Panelists offer perspective on the role of finerenone in combination therapy approaches in patients with HFmrEF/HFpEF.

Panelists discuss how to integrate finerenone into treatment algorithms for HFpEF

Finerenone's FDA Approval Marks a Turning Point in HFpEF Management

The July 2025 approval of finerenone (Kerendia) by the 

 with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) could serve as a watershed moment for cardiology in the coming years. 

Buoyed by results from the phase 3 FINEARTS-HF trial, the therapy, a first-in-class nonsteroidal mineralocorticoid receptor antagonist (nsMRA), stands poised to become a pillar of therapy for this patient population. 

leading subject matter experts Stephen Greene, MD, Andrew Sauer, MD, and Muthiah Vaduganathan, MD, MPH, reflect on the recent FDA approval of finerenone. 

A key point of the discussion highlighted by Sauer was the broad applicability of finerenone. The pivotal FINEARTS-HF trial enrolled over 6,000 patients across 37 countries, and the benefits were consistent across subgroups, reinforcing the idea that this is not a niche therapy but rather one with wide clinical utility.

The panelists also addressed the timing of benefit. Vaduganathan points out that, contrary to assumptions MRAs act only through long-term structural effects, early improvements were observed within 28 days of initiation—both in clinical endpoints and in patient-reported quality of life. These early signals strengthen the case for prompt therapy initiation, even in acute or recently hospitalized patients.

The panel shines light on ongoing trials like REDEFINE-HF and CONFIRMATION-HF, which they believe will further clarify implementation pathways in real-world settings. Overall, the discussion underscored a paradigm shift: HFpEF is now a condition with clearly actionable therapies, and clinicians have growing tools to improve outcomes with timely, multi-mechanism treatment strategies.

Finerenone's FDA approval marks a transformative step in heart failure treatment, offering early benefits and broad applicability.

Panelists discuss results of the FINEARTS-HF trial and how it informs use of finerenone.

Finerenone Offers New Hope for HFpEF: Insights from the FINEARTS-HF Trial

In July 2025, the cardiology community welcomed a first-in-class approval with the potential to usher in a paradigm shift for the management of 

 with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) with the 

 approval of finerenone (Kerendia), a nonsteroidal mineralocorticoid receptor antagonist (nsMRA) from Bayer Pharmaceuticals. 

, Stephen Greene, MD, sat down with Muthiah Vaduganathan, MD, MPH, and Andrew Sauer, MD, to discuss the evolving treatment landscape for HFpEF and HFmrEF.

In the first segment, the discussion focuses on the pivotal FINEARTS-HF trial led by Vaduganathan, who served as investigator on the phase 3 trial. The trial enrolled over 6000 patients with an ejectrion fraction of 40% or more, randomizing them to finerenone or placebo. Over a median follow-up of 2.7 years, finerenone significantly reduced the composite primary endpoint of cardiovascular death or total heart failure events by 16% (rate ratio [RR], 0.84; 95% confidence interval [CI], 0.74 to 0.95; 

 = .007). This effect was driven primarily by reductions in hospitalizations (RR, 0.82; 95% CI, 0.71 to 0.94; 

Vaduganathan noted the safety profile was consistent with previous trials: a mild increase in potassium, a predictable dip in eGFR, and a modest blood pressure reduction of about 3 mmHg. These findings reinforce finerenone’s role as a nonsteroidal MRA that can be safely used in this population.

Greene emphasized the broader clinical impact noting that, together with SGLT2 inhibitors, finerenone adds to a growing toolbox for a population long seen as difficult to treat. 

Finerenone's FDA approval marks a breakthrough in heart failure treatment, significantly reducing cardiovascular events and hospitalizations for patients.

Andrew Sauer, MD

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