Heart failure & cardiomyopathiesRandomised controlled trial
Finerenone, Liver Biomarkers, and Heart Failure With Mildly Reduced/Preserved Ejection Fraction: An Analysis of FINEARTS-HF
- randomized, double-blind, placebo-controlled trial
Authors' conclusion
Baseline bilirubin concentration was an independent predictor of worse outcomes but did not modify the benefits of finerenone on morbidity and mortality in HF with mildly reduced or preserved ejection fraction. Finerenone reduced bilirubin and alkaline phosphatase, suggesting a possible decongestive effect in HF with mildly reduced or preserved ejection fraction.
Study context
- Population
- Patients with heart failure with left ventricular ejection fraction ≥40%, evidence of structural heart disease, and elevated NT-proBNP levelsenrolled, 5873 with available baseline bilirubin measurements
- Participants
- 6,001 patients
- Comparison
- finerenone compared with placebo, by baseline liver biomarkers
Primary result
As reported in the abstract
Elevated bilirubin among 5873 patients with available baseline bilirubin measurements
11.9%
Further findings
| Outcome | rate ratio (95% CI) | |
|---|---|---|
| Total worsening HF events and cardiovascular death, by bilirubin tertile — finerenone vs placebo · T1 [<0.4 mg/dL] | 0.94 (0.75–1.17) | |
| Total worsening HF events and cardiovascular death, by bilirubin tertile — finerenone vs placebo · T2 [0.5-0.6 mg/dL] | 0.83 (0.66–1.05) | |
| Total worsening HF events and cardiovascular death, by bilirubin tertile — finerenone vs placebo · T3 [≥0.7 mg/dL] | 0.77 (0.62–0.97) | |
| 0.512Rate ratio (log scale) |
- Total worsening heart failure (HF) events and cardiovascular death, by bilirubin tertile: P interaction =0.43
Association of bilirubin with total worsening HF events and cardiovascular death
- Higher bilirubin levels associated with greater risk of total worsening HF events and cardiovascular death
Bilirubin, alkaline phosphatase and transaminase levels
- Finerenone rapidly reduced bilirubin and alkaline phosphatase levels (but not transaminase levels) compared with placebo, effects sustained over time
Components of the primary outcome, all-cause death, KCCQ total symptom score
- Consistent effects across bilirubin levels
Original publication
Summarised from the published abstract; every number is checked against it