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S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study.
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Systolic Heart failure treatment withthe Ifinhibitor ivabradineTrial Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Aim of the HQoL substudy To evaluate whether heart rate (HR) reduction with ivabradine is associated with increased HQoL in parallel to a reduction of primary outcomes in SHIFT METHOD Kansas City Cardiomyopathy Questionnaire (KCCQ) was used at baseline, 4, 12, and 24 months after randomization Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
KCCQ • Disease specific, 23 items,ranging from 0 to 100 (higher score = better HQoL) • physical limitation • symptoms (frequency, burden) • quality of life • social interference • self-efficacy • Clinical Summary Score (CSS): Mean of the physical limitation and total symptom domains scores • Overall Summary Score (OSS): CCS + quality of life and social limitation scores Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Substudypopulation 2282 patients from 24 countries with a validated KCCQ 161 excluded 177 excluded KCCQ assessed in 1944 patients 968 patients ivabradine 976 patients placebo Median study duration: 24.5 months; maximum: 29.3 months Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Baseline characteristics Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Baseline background treatment Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Baseline characteristics by low, medium and higher KCCQ Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Incidence of the primary endpoint by class of KCCQ overall score in Placebo group (n=976) Incidence (%) P <0.001 <50 50-<75 ≥75 Time (months) Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Incidence of worsening HF by class of KCCQ overall score in Placebo group (n=976) Incidence (%) P <0.001 <50 50-<75 ≥75 Time (months) Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Overall summary scoreChange frombaseline – 12 months = 2.4, P <0.001 KCCQ OSS 6.7 4.3 75 71.9 69.6 70 65.2 65.3 65 60 55 Baseline Baseline M12 M12 Ivabradine (n=842) Placebo (n=839) Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Clinical summary scoreChange frombaseline – 12 Months = 1.8, P=0.018 5.0 3.3 KCCQ CSS 74.1 75 72.3 69.1 69 70 65 60 Baseline Baseline M12 M12 Ivabradine (n=842) Placebo (n=839) Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Mean of change KCCQ Overall Summary Score at 12 months by quintiles of HR change P =<0.001 Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com
Conclusions • In symptomatic patients with systolic heart failure and elevated heart rate: • Lower HQoL is associated with increased risk for cardiovascular outcomes. • Elevated heart rate at rest is associated with lower HQoL. • Heart rate reduction with Ivabradine improves HQoL. • The magnitude of HR reduction with Ivabradine is directly related to the degree of improvement in HQoL. Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):2395-404 www.shift-study.com