Dataset Information

Levosimendan improves exercise performance in patients with advanced chronic heart failure.

ABSTRACT:

Aims

Cardiopulmonary exercise test (CPET) provides parameters such as peak VO₂ and ventilation/CO₂ production (VE/VCO₂) slope, which are strong prognostic predictors in patients with stable advanced chronic heart failure (ADHF). The study aim was to evaluate the effects of the inodilator levosimendan on CPET in patients with ADHF under stable clinical conditions.

Methods and results

We enrolled patients with ADHF (peak VO₂ < 12 mL/min/kg) in a double-blind, placebo-controlled protocol. Patients were randomly assigned to i.v. infusion of placebo (500 mL 5% glucose; n = 19) or levosimendan (in 500 mL 5% glucose; n = 23). Before and 24 h after the end of the infusion, patients underwent determination of New York Heart Association class, B-type natriuretic peptide (BNP), haemoglobin, serum creatinine, and blood urea nitrogen levels, as well as CPET, standard spirometry, and alveolar capillary gas diffusion. BNP showed no change with placebo (1042 ± 811 to 1043 ± 867 pg/mL), but it was decreased with levosimendan (1163 ± 897 to 509 ± 543 pg/mL, P < 0.001). No changes were observed for haemoglobin, creatinine, and blood urea nitrogen in either group. With levosimendan, a minor improvement was observed in spirometry measurements, but not in alveolar capillary gas diffusion. Peak VO₂ showed a small, non-significant increase with placebo (9.5 ± 1.7 to 10.0 ± 2.1 mL/kg/min, P = 0.12), and a greater increase with levosimendan (9.8 ± 1.7 to 11.0 ± 1.9 mL/kg/min, P < 0.005). The VE/VCO₂ slope showed no change (44.0 ± 11 vs. 43.4 ± 10.3, P = 0.44), and a decrease (41.9 ± 10 vs. 36.6 ± 6.4, P < 0.001) in the placebo and in the levosimendan group, respectively.

Conclusion

Levosimendan treatment significantly improves peak VO₂ and reduces VE/VCO₂ slope and BNP in patients with ADHF.

SUBMITTER: Mushtaq S

PROVIDER: S-EPMC5042087 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Levosimendan improves exercise performance in patients with advanced chronic heart failure.

Mushtaq Saima S Andreini Daniele D Farina Stefania S Salvioni Elisabetta E Pontone Gianluca G Sciomer Susanna S Volpato Valentina V Agostoni Piergiuseppe P

ESC heart failure 20150813 3

<h4>Aims</h4>Cardiopulmonary exercise test (CPET) provides parameters such as peak VO<sub>2</sub> and ventilation/CO<sub>2</sub> production (VE/VCO<sub>2</sub>) slope, which are strong prognostic predictors in patients with stable advanced chronic heart failure (ADHF). The study aim was to evaluate the effects of the inodilator levosimendan on CPET in patients with ADHF under stable clinical conditions.<h4>Methods and results</h4>We enrolled patients with ADHF (peak VO<sub>2</sub> < 12 mL/min/kg ...[more]

PMID: 27708855

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Project description:AimsWe report the results of a real-world study based on heart failure (HF) patients' continuous remote monitoring strategy using the CardioMEMS system to assess the impact of this device on healthcare outcomes, costs, and patients' management and quality of life.Methods and resultsWe enrolled seven patients (69.00 ± 4.88 years; 71.43% men) with HF, implanted with CardioMEMS, and daily remote monitored to optimize both tailored adjustments of home therapy and/or hospital infusions of levosimendan. We recorded clinical, pharmacological, biochemical, and echocardiographic parameters and data on hospitalizations, emergency room access, visits, and costs. Following the implantation of CardioMEMS, we observed a 50% reduction in the total number of hospitalizations and a 68.7% reduction in the number of days in the hospital. Accordingly, improved patient quality of life was recorded with EQ-5D (pre 58.57 ± 10.29 vs. 1 year post 84.29 ± 19.02, P = 0.008). Echocardiographic data show a statistically significant improvement in both systolic pulmonary artery pressure (47.86 ± 8.67 vs. 35.14 ± 9.34, P = 0.022) and E/e' (19.33 ± 5.04 vs. 12.58 ± 3.53, P = 0.023). The Quantikine® HS High-Sensitivity Kit determined elevated interleukin-6 values at enrolment in all patients, with a statistically significant reduction after 6 months (P = 0.0211). From an economic point of view, the net savings, including the cost of CardioMEMS, were on average €1580 per patient during the entire period of observation, while the analysis performed 12 months after the implant vs. 12 months before showed a net saving of €860 per patient. The ad hoc analysis performed on the levosimendan infusions resulted in 315 days of hospital avoidance and a saving of €205 158 for the seven patients enrolled during the observation period.ConclusionsThis innovative strategy prevents unplanned access to the hospital and contributes to the efficient use of healthcare facilities, human resources, and costs.

Project description:AimsThe aim of the LAICA study was to evaluate the long-term effectiveness and safety of intermittent levosimendan infusion in patients with advanced heart failure (AdHF).Methods and resultsThis was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 μg/kg/min as a continuous 24-h intravenous infusion administered once monthly for 1 year in patients with AdHF. The primary endpoint [incidence of rehospitalization (admission to the emergency department or hospital ward for >12 h) for acute decompensated HF or clinical deterioration of the underlying HF] occurred in 23/70 (33%) of the levosimendan group (Group I) and 12/27 (44%) of the placebo group (Group II) (P = 0.286). The incidence of hospital readmissions for acute decompensated HF (Group I vs. Group II) at 1, 3, 6, and 12 months was 4.2% vs. 18.2% (P = 0.036); 12.8% vs. 33.3% (P = 0.02); 25.7% vs. 40.7% (P = 0.147); 32.8% vs. 44.4% (P = 0.28), respectively. In a secondary pre-specified time-to-event analysis no differences were observed in admission for acute decompensated HF between patients treated with levosimendan compared with placebo (hazard ratio 0.66; 95% CI, 0.32-1.32; P = 0.24). Cumulative incidence for the aggregated endpoint of acute decompensation of HF and/or death at 1 and 3 months were significatively lower in the levosimendan group than in placebo group [5.7% vs. 25.9% (P = 0.004) and 17.1% vs. 48.1% (P = 0.001), respectively], but not at 6 and 12 months [34.2% vs. 59.2% (P = 0.025); 41.4% vs. 66.6% (P = 0.022), respectively]. Survival probability was significantly higher in patients who received levosimendan compared with those who received placebo (log rank: 4.06; P = 0.044). There were no clinically relevant differences in tolerability between levosimendan and placebo and no new safety signals were observed.ConclusionsIn our study, intermittent levosimendan in patients with AdHF produced a statistically non-significant reduction in the incidence of hospital readmissions for acute decompensated HF, a significantly lower cumulative incidence of acute decompensation of HF and/or death at 1 and 3 month of treatment and a significant improvement in survival during 12 months of treatment.

Dataset Information

Levosimendan improves exercise performance in patients with advanced chronic heart failure.

Aims

Methods and results

Conclusion

Publications

Levosimendan improves exercise performance in patients with advanced chronic heart failure.

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