Levosimendan treatment for acutely decompensated heart failure is as effective for Chagas disease patients as for patients with other etiologies

Objectives

The BELIEF study was designed to evaluate the safety and efficacy of a 24-hour levosimendan (Levo) infusion for the treatment of acutely decompensated heart failure (HF) patients. The primary endpoint was to check the proportion of patients who have been discharged from hospital without the need of using inotropes, other than Levo. In this subset, we investigated whether the Chagas disease (CD) subgroup has had the same hemodynamic benefits and achieved the primary endpoint compared with non-CD patients.

Methods

The BELIEF study was a multicentric trial, in which 156 acutely decompensated New York Heart Association class IV HF patients, mostly male (68%), mean age 56 years old, have received a 24-hour Levo infusion of 0.05–0.2 μg/kg/min. The patients have been diagnosed with HF 6 years ago, with a mean of 2.99 hospitalizations within the past year. The initial systolic blood pressure (SBP) was 110.8 mmHg (70–180 mmHg). Twenty-eight patients (22.4%) had CD as the HF etiology, 42 were due to ischemic disease and 38 were idiopathic.

Results

One hundred and twenty-five patients (78.6%) have achieved the primary endpoint. The same proportion was seen in the CD patient subset, when compared with the non-CD group (75% vs 79.3%, P = 0.813). CD patients had the same mean age, sex distribution and clinical features as the non-CD patients. The CD group had more frequent hypotension when compared with the non-CD group (28.5% vs 15.4%, P = 0.0195). The dilated myocardiopathy group also had the same incidence of hypotension as the CD group (28.5% vs 34.2%, P = 0.826).

Conclusion

CD patients with acutely decompensated HF had the same hemodynamic benefits as HF patients with other etiologies treated with Levo. Three-quarters of CD patients have been discharged from the hospital without the need for inotropes after Levo treatment. Although hypotension was slightly more frequent in the CD group, it did not reduce the Levo response in this group of patients.