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 Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

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):

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):

968 patients ivabradine 968 patients ivabradine 976 patients placebo 976 patients placebo 161 excluded KCCQ assessed in 1944 patients 177 excluded 177 excluded 2282 patients from 24 countries with a validated KCCQ 2282 patients from 24 countries with a validated KCCQ Substudy population Median study duration: 24.5 months; maximum: 29.3 months Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

Baseline characteristics Ivabradinen=968Placebon=976 Mean age, years Mean age, years6161 Male, % Male, %7577 BMI, kg/m 2 BMI, kg/m Mean HF duration, years Mean HF duration, years44 HF ischaemic cause, % HF ischaemic cause, %6563 NYHA class II, % NYHA class II, %5957 NYHA class III, % NYHA class III, %4042 NYHA class IV, % NYHA class IV, %11 Mean LVEF, % Mean LVEF, %2828 Mean HR, bpm Mean HR, bpm Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

Baseline background treatment Ivabradinen=968Placebon=976 Beta-blocker, % Beta-blocker, %9091 ACE inhibitor, % ACE inhibitor, %8183 ARB, % ARB, %1615 Diuretics, % Diuretics, %8583 Aldosterone antagonist, % Aldosterone antagonist, %6764 Digitalis, % Digitalis, %19 Devices, % Devices, % 57 Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

Baseline characteristics by low, medium and higher KCCQ Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

Incidence (%) Time (months) ≥75 50-<75 <50 Incidence of the primary endpoint by class of KCCQ overall score in Incidence of the primary endpoint by class of KCCQ overall score in Placebo group (n=976) P < Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

Time (months) <50 50-<75 ≥75 Incidence of worsening HF by class of KCCQ overall score in Placebo group (n=976) P <0.001 Incidence (%) Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

 = 2.4, P <0.001 Overall summary score Overall summary score Change from baseline – 12 months Ivabradine (n=842) Baseline M12 Placebo (n=839) Baseline M  6.7  4.3 KCCQ OSS Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

Clinical summary score Clinical summary score Change from baseline – 12 Months  = 1.8, P= Ivabradine (n=842) Baseline M12 Placebo (n=839) Baseline M  5.0  3.3 KCCQ CSS Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

P =<0.001 Mean of change KCCQ Overall Summary Score at 12 months by quintiles of HR change Ekman I, Chassany O, Komajda M, et al. Eur Heart J. 2011;32(19):

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):