FINEARTS-HF (original research)
Trial question
What is the role of finerenone in patients with HFmrEF or HFpEF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 6001
6001 patients (2732 female, 3269 male).
Inclusion criteria: patients with HF and a LVEF ≥ 40%.
Key exclusion criteria: eGFR < 25 mL/min/1.73 m²; serum potassium > 5.0 mmol/L; acute inflammatory heart disease; MI or any event that could have led to reduced ejection fraction in the past 90 days; CABG surgery in the past 90 days.
Interventions
N=3003 finerenone (at a maximum dose of 20-40 mg once daily plus usual therapy).
N=2998 placebo (matching placebo once daily plus usual therapy).
Primary outcome
Incidence of total worsening heart failure events and CV death
14.9
17.7
17.7/100 py
13.3/100 py
8.8/100 py
4.4/100 py
0.0/100 py
Finerenone
Placebo
Significant
decrease ▼
Significant decrease in the incidence of total worsening HF events and CV death (14.9 events /100 py vs. 17.7 events /100 py; RR 0.84, 95% CI 0.74 to 0.95).
Secondary outcomes
Significantly greater improvement in Kansas City Cardiomyopathy Questionnaire total symptom score at 6, 9, and 12 months (8 points vs. 6.4 points; AD 1.6 points, 95% CI 0.8 to 2.3).
No significant difference in improvement in NYHA functional class at 12 months (18.6% vs. 18.4%; OR 1.01, 95% CI 0.88 to 1.15).
No significant difference in death from any cause (16.4% vs. 17.4%; HR 0.93, 95% CI 0.83 to 1.06).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with HF and a LVEF ≥ 40%, finerenone was superior to placebo with respect to the incidence of total worsening HF events and CV death.
Reference
Scott D Solomon, John J V McMurray, Muthiah Vaduganathan et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024 Oct 24;391(16):1475-1485.
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