Transportability of the comparative effect of finerenone for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction of ≥40%: insights from the FINEARTS-HF trial
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: Global randomized controlled trials (RCTs) are used to inform reimbursement decisions in multiple markets, meaning the transportability of findings from these RCTs to multiple country-specific populations is critical for evidence-based decision making. This study evaluated the transportability of the FINEARTS-HF trial, which assessed finerenone in patients with heart failure (HF) and left ventricular ejection fraction ≥40%, to a real-world US population. Materials & methods: A three-phase transportability assessment was conducted. First, potential effect modifiers were identified through systematic literature review and confirmed through interaction analyses using data from FINEARTS-HF. Second, representativeness was assessed by comparing the distribution of effect modifiers in the trial and a population derived from a US electronic health record dataset. Third, direct proxy tests explored heterogeneity of treatment effects in FINEARTS-HF between US and non-US patients. Results: Effect modifier analysis identified that treatment effects of finerenone were homogeneous across subgroups, with limited evidence of effect modification. Comparisons with the US target population indicated overall good alignment across key characteristics, with only modest imbalances, suggesting that the trial results may underestimate positive treatment effects in the US target population (i.e., effect on the primary outcome over 0.84 [0.74; 0.95]). Direct proxy tests found no statistically significant regional heterogeneity in treatment effects. Conclusion: This study provides a structured assessment of finerenone trial transportability. Findings support the robustness of FINEARTS-HF results for US clinical practice and are not impacted by the prevalence of SGLT2-is use. The risk of transportability bias is likely to be low.
Plain language summary: Can results from a global heart failure trial be used in different countries?
What is this article about?
Clinical trials are often run in many countries. However, patients from trials may not always look the same as patients treated in everyday clinical practice in a specific country. This raises an important question: can results from a trial be reliably used to inform decisions at a country level? This article examines whether the results of the FINEARTS-HF trial, evaluating finerenone in patients with chronic heart failure and a left ventricular ejection fraction ≥40%, are applicable to patients from the US.
How was this assessed?
The researchers used a step-by-step approach. First, they identified patient characteristics that could influence how well the treatment works. Next, they compared these characteristics between people in the trial and patients treated in routine care in the US. Finally, they checked whether the treatment worked differently in patients enrolled in the US compared with those enrolled in other countries.
What were the results?
The people included in the trial were similar to patients treated in routine practice. There was no evidence that finerenone worked differently in one country compared with another. The small differences observed suggest that the trial results may slightly underestimate how much benefit patients could experience.
What do the results mean?
Using the US as an example, the study shows that results from the FINEARTS-HF trial can be applied with confidence across different healthcare settings. This approach can help decision-makers judge whether results from global clinical trials are relevant in their own countries.
Graphical abstract
Supplementary Material
Reference
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© 2026 Bayer AG, HEOR & HTA, Wuppertal, Germany. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
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Received: 9 January 2026
Accepted: 31 March 2026
Published online: 6 May 2026
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Transportability of the comparative effect of finerenone for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction of ≥40%: insights from the FINEARTS-HF trial. (2026) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2026-0003
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