Finerenone and Outpatient Worsening Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.

Summary

In 6001 patients with HF and LVEF ≥40%, outpatient oral diuretic intensification events were common, carried a poor prognosis (11.6 deaths/100 patient-years), and finerenone significantly reduced these events (HR 0.89) and an extended composite including CV death, HF hospitalization, and urgent HF visits (HR 0.85). Incorporating outpatient intensifications substantially increased event capture (1343 to 2238 patients).

Key Findings

• Outpatient oral diuretic intensification was common (n=1250 first events) and associated with higher mortality (11.6 per 100 patient-years).
• Finerenone reduced outpatient diuretic intensification events (HR 0.89, 95% CI 0.80–0.98; P=0.02).
• Finerenone reduced an extended composite including CV death, HF hospitalization, urgent HF visit, and outpatient intensification (HR 0.85, 95% CI 0.78–0.92; P<.001).

Clinical Implications

Clinicians should recognize outpatient diuretic intensifications as prognostically important and consider finerenone for patients with LVEF ≥40% to reduce worsening events alongside standard care, pending label and guideline alignment.

Limitations

• Secondary analysis; randomization not stratified by outpatient event risk.
• Effect on hard clinical outcomes in isolation of outpatient intensification remains inferential.

Future Directions

Prospective trials incorporating outpatient diuretic intensification as an adjudicated endpoint; subgroup analyses to identify responders; pragmatic studies in real-world HFpEF/HFmrEF populations.