What is the clinical evidence from this study?

Study design: Cohort. Population: Chronic heart failure with reduced ejection fraction (n=86). Intervention: Baseline B-type natriuretic peptide (BNP) vs. Lower baseline BNP. Primary outcome: Long-term all-cause mortality (HR 2.09, 95% CI 1.26-3.45, p=0.004).

April 5, 2013Open Access

Serum biomarkers and clinical outcomes in heart failure patients treated de novo with carvedilol

JNJadwiga NesslerJohn Paul II Hospital BNBohdan NesslerJagiellonian University RGRenata Gołębiowska-WiatrakJohn Paul II Hospital

Key Result

Higher baseline B-type natriuretic peptide (BNP) was strongly associated with increased long-term mortality (HR 2.09 per 1 SD increase) in heart failure patients treated with carvedilol.

Study Design

Type

Cohort (n=86)

Blinding

Open-label

Multicenter

Structured PICO

Do baseline levels and on-treatment changes of serum biomarkers predict clinical outcomes and left ventricular improvement in heart failure patients treated de novo with carvedilol?

Population

86 patients (mean age 56 years, 5.8% female) with symptomatic chronic heart failure and LVEF < 40%, previously untreated with beta-blockers, followed for an average of 9 years after initiating carvedilol.

Exposure

Carvedilol initiated at 3.125 mg twice a day for 2 weeks and titrated to a mean dose of 25.8 ± 15.2 mg/day at 12 months, added to background therapy (ACEi/ARB, diuretics, spironolactone).

Outcome

Long-term mortality, frequent hospital admissions (>1) for cardiac complications, and improvement of left ventricular function (LVEF and LVESVI) at 12 months.

In patients with heart failure starting carvedilol, different serum biomarkers predict distinct clinical outcomes: baseline BNP predicts long-term mortality, ET-1 predicts frequent hospitalizations, and CRP predicts left ventricular functional improvement.

Main Result

Hazard Ratio: 2.09 (95% CI 1.26–3.45)

p-value: p=0.004

Limitations

Small study sample with very few female participants
Open-label study design might potentially introduce bias
No control group without beta-blocker treatment
High proportion of ischemic heart failure limits extrapolation to non-ischemic etiology
Lack of data on smoking status introduces potential residual confounding

Abstract

BACKGROUND: The role of inflammatory and hemodynamic stress biomarkers in heart failure (HF) patients treated de novo with beta-blockers has been poorly studied. METHODS: A total of 86 patients (age 56 ± 9 years, 81 men) with left ventricular ejection fraction (LVEF) 1) for cardiac complications (odds ratio per one SD: 1.98; 95% CI: 1.09-3.59; p = 0.025, and 2.07, 1.12-3.84, p = 0.021, respectively) whereas higher baseline BNP was associated with increased mortality (hazard ratio per one SD: 2.09, 95% CI: 1.26-3.45; p = 0.004). CONCLUSIONS: Serum biomarkers may have different roles in prediction of clinical outcomes among HF patients treated de novo with carvedilol.

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