Finerenone Shows Favorable Real-World Profile in Chinese Heart Failure Patients

Heart failure remains one of the most stubborn killers in modern medicine. In China alone, more than ten million people aged 35 or older live with the condition, and despite decades of progress in drug and device therapy, the five-year survival rate hovers around just 50 percent. Now, a team of cardiologists at Tongji Hospital in Shanghai has published one of the first real-world looks at how finerenone, a next-generation mineralocorticoid receptor antagonist, performs in routine Chinese clinical practice, and the results offer a cautiously encouraging picture for patients across the entire spectrum of the disease.

Finerenone belongs to a class of drugs called mineralocorticoid receptor antagonists, or MRAs. The first-generation steroidal MRA spironolactone and the second-generation eplerenone significantly reduce mortality and hospitalization risk in heart failure with reduced ejection fraction, the form in which the heart’s pumping capacity is severely weakened, and guidelines support their use in that population. But in heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction, the efficacy of traditional MRAs remains unclear, a point underscored by the TOPCAT study despite its criticisms, leaving guidelines conservative about MRAs in those groups. Finerenone is technically distinct: it is a nonsteroidal molecule with higher receptor selectivity and different physicochemical properties, with a more balanced distribution in heart and kidney tissue than traditional steroidal MRAs.

The drug’s rise has been rapid. Approved in 2021 in the United States and in 2022 by the European Union and China for chronic kidney disease associated with type 2 diabetes, finerenone demonstrated in the FIDELIO-DKD and FIGARO-DKD trials that it could reduce the urinary albumin-to-creatinine ratio, delay the progression of renal function loss, and significantly reduce new-onset heart failure events, with prespecified subgroup analyses showing consistent clinical benefits regardless of whether patients had concurrent heart failure. Then, in 2024, the FINEARTS-HF study delivered the finding that changed the field: in patients with heart failure and a left ventricular ejection fraction of at least 40 percent, finerenone significantly reduced the composite risk of heart failure worsening and cardiovascular death, and improved patient-reported Kansas City Cardiomyopathy Questionnaire scores. That evidence secured approval for the heart failure indication in the United States, Canada, and Japan in 2025.

Yet a critical gap remained. The new heart failure indication rests almost entirely on non-Chinese data, and China’s National Medical Products Administration has not yet approved it. Previous comparisons have shown that hospitalized heart failure patients in China are younger, receive less ACE inhibitor, ARB, and beta-blocker therapy, and carry different comorbidity profiles than Scandinavian and European cohorts, even though short-term prognosis is broadly similar when age-adjusted. Extrapolating trial results conducted largely in Europe and North America to Chinese patients is therefore uncertain, particularly regarding background therapy, age distribution, ischemic burden, and biomarker profiles. This is precisely the kind of evidence gap that real-world observational studies are designed to fill, capturing how drugs behave amid complex comorbidities, polypharmacy, and varying treatment adherence.

The Tongji Hospital study, published in Frontiers in Cardiovascular Medicine, was a single-center retrospective observational analysis of 73 consecutive patients diagnosed with heart failure and treated with add-on finerenone between August 2023 and May 2024. All patients received finerenone at 10 mg once daily on top of standard treatment and completed at least 12 months of follow-up. Patients taking strong CYP3A4 inhibitors, those with baseline serum potassium above 5.0 mmol/L, those with an estimated glomerular filtration rate below 25 mL/min/1.73 m2, and those with hemodynamically unstable acute heart failure were excluded. The cohort was elderly and comorbidity-laden: the median age was 72 years, roughly two-thirds were male, coronary heart disease affected 68.5 percent, hypertension 65.8 percent, and type 2 diabetes 52.1 percent. Patients with preserved ejection fraction formed the largest group at 63.0 percent, with mildly reduced and reduced ejection fraction accounting for 17.8 and 19.2 percent respectively. The baseline median NT-proBNP of 1,496.85 pg/mL indicated a population at high risk of decompensation.

The treatment context matters for interpreting the results. Among the patients, 25, or 34.2 percent, were hospitalized for acute decompensated heart failure and received intravenous loop diuretics; in these patients, finerenone was initiated prior to discharge once clinical and hemodynamic stabilization was achieved, and a subset also newly initiated SGLT2 inhibitors during the same hospitalization. The remaining 48 patients started finerenone in the outpatient setting. Patients with reduced ejection fraction were switched to finerenone because of spironolactone intolerance, such as gynecomastia, and local unavailability of eplerenone, whereas those with preserved or mildly reduced ejection fraction initiated the drug primarily for comorbid chronic kidney disease or type 2 diabetes, or as clinician-directed therapy for persistent symptoms. Across the cohort, RASi use was 86.3 percent, beta-blockers 52.1 percent, SGLT2 inhibitors 53.4 percent, and loop diuretics 64.4 percent, and aside from diuretic adjustments, all other background medications remained unchanged throughout follow-up.

Over 12 months, the researchers tracked a series of favorable longitudinal changes in cardiac structure, diastolic function, biomarkers, and symptoms. The left atrial diameter shrank from a median of 50 mm at baseline to 49 mm at six months and 48 mm at one year, a statistically significant change. The E/e’ ratio, an echocardiographic index reflecting left ventricular filling pressure, fell from a median of 10.65 to 9.20 at six months and 8.20 at 12 months. Most strikingly, NT-proBNP declined progressively throughout follow-up, dropping 30.41 percent by three months and reaching a 67.47 percent reduction at 12 months. New York Heart Association functional class shifted as well: at baseline every patient had symptoms, with 58.9 percent in Class II and 41.1 percent in Class III, but by one year 100 percent were in Class I or II. Left ventricular ejection fraction showed a modest overall increase.

The trends were broadly similar across the three ejection fraction subgroups, with NT-proBNP reductions of 68.82 percent in HFpEF, 69.11 percent in HFmrEF, and 54.55 percent in HFrEF. The ejection fraction improvement was far more pronounced in the HFrEF subgroup, where the median climbed from 34.5 to 47.5 percent, a gain of 10.5 percentage points, compared with 5.0 points in HFmrEF and 1.0 point in HFpEF. The authors urge caution here, however. The HFrEF subgroup contained only 14 patients, and the improvement likely reflects the small sample size, functional recovery following recent acute decompensation, and the cumulative remodeling benefits of background quadruple therapy, including ARNIs and SGLT2 inhibitors, rather than a standalone pharmacological effect of finerenone. Subgroup findings with smaller sample sizes are considered exploratory, and missing echocardiographic data were not imputed.

Safety was a central focus, and the profile proved encouraging. No patients discontinued finerenone because of adverse events during the entire study. Serum potassium, the most watched laboratory parameter with any MRA, rose from a baseline median of 3.90 mmol/L to 4.20 mmol/L at one month and then stabilized at a plateau of 4.10 to 4.15 mmol/L. Only three patients, or 4.1 percent, reached potassium levels of 5.0 mmol/L or above, and none experienced severe hyperkalemia above 5.5 mmol/L. Episodes of hypokalemia below 3.5 mmol/L occurred in four patients, and none of the potassium abnormalities led to discontinuation or hospitalization. Kidney function showed a transient, slight dip, with the median eGFR falling to 63.30 mL/min/1.73 m2 at three months without significant difference from baseline, before recovering to 70.10 mL/min/1.73 m2 at 12 months; declines greater than 30 percent from baseline were observed in small numbers of patients at each time point and were mostly transient. Blood pressure declined significantly from 127.37/73.21 mmHg at baseline to about 121/69 mmHg at one month and remained stable, with no symptomatic hypotension requiring drug withdrawal. Eight patients, 11.0 percent, were readmitted for heart failure, and seven, 9.6 percent, required diuretic dose escalation.

The authors are careful to contextualize their own findings, and that intellectual honesty matters for readers weighing the hype. One-third of the cohort had recently been hospitalized for acute decompensated heart failure, and because natriuretic peptide levels surge during decompensation, a substantial portion of the dramatic NT-proBNP decline inevitably reflects natural post-discharge recovery following intravenous diuretic decongestion. Some hospitalized patients also newly initiated SGLT2 inhibitors during the same admission, adding synergistic unloading to the mix. In an unblinded, single-arm design without a control group, clinician-assessed NYHA class is inherently susceptible to observer and expectation bias, as well as survivorship bias among patients who completed follow-up. The study explicitly frames its results as associations, not evidence of a causal treatment effect, and calls for larger, multicenter randomized controlled trials to validate the observations. Even so, the direction of the echocardiographic improvements mirrors what spironolactone achieved on diastolic function in the Aldo-DHF study, the ARTS-HF trial found finerenone non-inferior to eplerenone for achieving greater than 30 percent NT-proBNP reduction in HFrEF, and the low hyperkalemia rate may partly stem from the cohort’s high SGLT2 inhibitor use, since those drugs promote potassium excretion. For Chinese patients, whose phenotypes and background therapies differ from the Western populations that dominate finerenone’s trial evidence, this descriptive real-world dataset provides a first local signal that the drug is tolerable and associated with favorable clinical trajectories, supporting the ongoing trial of finerenone in spironolactone-intolerant HFrEF patients and the broader effort to validate its heart failure benefit in China.

Subject of Research: Real-world observational study of finerenone clinical outcomes and safety in Chinese patients with heart failure

Article Title: Clinical outcomes and safety of finerenone in patients with heart failure: a real-world observational study in China

Article References: Zhao, C., Sun, B., Xu, H., Yao, Y., Huang, F., & Liu, X. (2026). Clinical outcomes and safety of finerenone in patients with heart failure: a real-world observational study in China. Frontiers in Cardiovascular Medicine, 13, Article 1982954. https://doi.org/10.3389/fcvm.2026.1982954

Image Credits: AI Generated

DOI: 10.3389/fcvm.2026.1982954

Keywords: finerenone, heart failure, HFpEF, HFrEF, HFmrEF, NT-proBNP, mineralocorticoid receptor antagonist, real-world study, China, cardiology, hyperkalemia, echocardiography