S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial
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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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S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial

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S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

  • 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

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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

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

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

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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


S ystolic h eart failure treatment with the i f inhibitor ivabradine t rial

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

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


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