Is Kerendia (finerenone) safe for a patient with heart failure and frequent volume overload?

Kerendia (Finerenone) Safety in Heart Failure with Frequent Volume Overload

Kerendia (finerenone) can be used safely in patients with heart failure and frequent volume overload, but requires careful monitoring for hyperkalemia and hypotension, with particular attention to concurrent diuretic management and renal function. 1, 2, 3

Evidence Supporting Safety and Efficacy

Clinical Trial Data in Heart Failure with Volume Overload

• The FINEARTS-HF trial specifically enrolled patients requiring diuretic use for at least 30 days prior to enrollment, demonstrating that finerenone was studied in the exact population you're asking about—patients with chronic volume management needs 4, 1

• Finerenone reduced cardiovascular death and total worsening heart failure events (rate ratio 0.84,95% CI 0.74-0.95) across all ejection fractions ≥40%, including patients with frequent volume overload 1

• Patients with recent worsening heart failure events (enrolled during or within 7 days of hospitalization) showed even greater absolute benefit from finerenone (RR 0.74,95% CI 0.57-0.95), suggesting the drug is particularly effective in those with active volume management challenges 2

Key Safety Considerations

Hyperkalemia Risk

• Finerenone increases hyperkalemia risk approximately 2-fold (RR 2.07,95% CI 1.77-2.44) compared to placebo, regardless of heart failure phenotype 3

• However, finerenone causes significantly less hyperkalemia than spironolactone (RR 0.41,95% CI 0.21-0.79) in HFrEF patients, making it a safer mineralocorticoid receptor antagonist option 3

• Patients with serum potassium >5.0 mmol/L were excluded from FINEARTS-HF, establishing this as a practical safety threshold before initiation 4

Hypotension Risk

• Finerenone increases hypotension risk by approximately 50% (RR 1.49,95% CI 1.31-1.68) compared to placebo 3

• Critically, hypotension risk was NOT increased in patients with recent worsening heart failure who were on finerenone, despite these patients requiring aggressive diuresis 2

• This finding directly addresses your concern: the drug can be used even during active volume overload management without excessive hypotension risk 2

Renal Function Monitoring

• Patients with eGFR <25 mL/min/1.73 m² were excluded from trials, establishing a minimum renal function threshold 4

• Finerenone showed consistent benefits across all eGFR categories ≥25 mL/min/1.73 m², including those with moderate-to-severe CKD who are at highest risk for volume overload 5

• The risk of worsening renal function was not increased with finerenone, even in patients with recent worsening heart failure requiring intensive diuresis 2

Practical Management Algorithm

Patient Selection

• Confirm serum potassium ≤5.0 mmol/L before initiating finerenone 4

• Verify eGFR ≥25 mL/min/1.73 m² as minimum threshold 4

• Do not withhold finerenone solely because of frequent volume overload—this was the studied population 4, 2

Concurrent Diuretic Management

• Continue loop diuretics as needed for volume management; finerenone does not replace diuretic therapy 6, 7

• Cautious diuresis should proceed even in presence of mild hypotension (as long as patient remains asymptomatic), as reducing preload improves right ventricular function in volume overload states 6

• Consider combination diuretic therapy (loop diuretic plus thiazide-type) if volume overload persists, but monitor potassium more frequently when adding finerenone 7

Monitoring Strategy

• Check potassium and renal function within 4 weeks of initiation, then regularly thereafter based on clinical stability 4

• If potassium rises to 5.5-6.0 mmol/L: reduce finerenone dose or temporarily discontinue; adjust other potassium-affecting medications 8

• If symptomatic hypotension develops: assess volume status first—if truly volume overloaded, continue finerenone and optimize diuretic regimen rather than discontinuing the MRA 6, 2

Critical Pitfalls to Avoid

Common Misconception About Volume Overload

• Do not assume that volume overload contraindicates finerenone—the opposite is true: patients requiring chronic diuretics were specifically the target population in FINEARTS-HF 4, 2

• Volume overload with hypotension is NOT a contraindication to finerenone; this paradoxical state (high preload, low output) may actually benefit from MRA therapy to reduce maladaptive neurohormonal activation 6

Drug Interaction Concerns

• Elderly patients are at higher risk for hyperkalemia when combining aldosterone antagonists with ACE inhibitors/ARBs, but this combination is often necessary and can be managed with monitoring 8

• NSAIDs significantly increase hyperkalemia risk with any MRA and should be avoided or used with extreme caution 8

Comparison to Older MRAs

• Finerenone demonstrates superior tolerability compared to spironolactone, with lower rates of treatment discontinuation (RR 0.37,95% CI 0.25-0.54) and fewer overall adverse events 3

• Compared to eplerenone, finerenone shows fewer treatment-emergent serious adverse events (RR 0.74,95% CI 0.66-0.84) with similar discontinuation rates 3

Bottom Line for Clinical Practice

Kerendia is safe and effective specifically in heart failure patients with frequent volume overload who require ongoing diuretic therapy. The key is appropriate patient selection (potassium ≤5.0 mmol/L, eGFR ≥25 mL/min/1.73 m²) and vigilant monitoring for hyperkalemia, which is manageable and occurs less frequently than with older MRAs. 4, 1, 2, 3 The presence of volume overload requiring diuretics is not a contraindication—it was the inclusion criterion for the pivotal trial. 4