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

S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial. Objective, design and baseline. Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81. www.shift-study.com. Swedberg K, et al. Lancet . 2010;376(9744):875-885. Primary objective.

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

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  1. Systolic Heart failure treatment withthe Ifinhibitor ivabradineTrial Objective, design and baseline Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81 www.shift-study.com Swedberg K, et al. Lancet. 2010;376(9744):875-885

  2. Primary objective To evaluate whether the If inhibitor ivabradine improves cardiovascular outcomes in patients with 1. Moderate to severe chronic heart failure 2. Left ventricular ejection fraction 35% 3. Heart rate 70 bpm in sinus rhythm 4. Best recommended therapy www.shift-study.com Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81

  3. Study organisation Executive CommitteeM. Komajda co-chair, K. Swedberg co-chair M. Böhm, J. Borer, I. Ford, L. Tavazzi SteeringCommittee Germany: K. Werdan Greece: D. Kremastinos Hong-Kong: C. Yu Hungary: K. Tóth India: D. S. Rao Ireland: K. Mc Donald Italy: M. Metra Latvia: J. Jirgenson† A. Erglis Lithuania: A. Kavoliuniene Malaysia: K. Sim The Netherlands:A. Voors Norway: K. Dickstein Poland: G. Opolski Portugal: L. Providência Romania: D. Ionescu Russia: G. Aroutiounov Slovakia: R. Hatala Slovenia: M. Sebestjen South Korea: B. Oh Spain: F. Avilés Sweden: R. Willenheimer Turkey: A. Oto United Kingdom: M. Cowie Ukraine: O. Parkhomenko Argentina: S. Perrone Australia: H. Krum Belgium: W. Van Mieghem Brazil: E. Bocchi Bulgaria: T. Katova Canada: P. Liu Chile: J. Jalil China: D. Hu CzechRepublic: J. Vitovec Denmark: L. Køber Estonia: T. Uuetoa Finland: M. Niemelä France: G. Jondeau

  4. A landmark trial in heart failure Europe Austria Belgium Bulgaria Denmark Finland France Germany Greece Ireland Italy The Netherlands Portugal Spain Sweden Turkey UK Czech Republic Estonia Hungary Latvia Lithuania Norway Poland Romania Russia Slovakia Slovenia Ukraine North America Canada South America Argentina Brazil Chili Asia China Hong Kong India South Korea Malaysia Australia 6505 patients, 37 countries, 677 centres

  5. Inclusion criteria • 18 years • Class II to IV NYHA heart failure • Ischaemic/non-ischaemicaetiology • LV systolic dysfunction (EF 35%) • Heart rate 70 bpm • Sinus rhythm • Documented hospital admission for worsening heart failure 12 months Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81

  6. 3.5 years Study design Ivabradine 7.5/5/2.5 mg bidaccording to Ivabradine 5 mg bid HR and tolerability Screening 7 to 30 days Matching placebo, bid Every 4 months D0 D14 D28 M4 Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81

  7. Study endpoints Primary composite endpoint • Cardiovascular death • Hospitalization for worsening heart failure Other endpoints • All-cause / CV / HF death • All-cause / CV / HF hospitalization • Composite of CV death, hospitalization for HF or non-fatal MI • NYHA class / Patient & Physician Global Assessment In total population and in patients withat least 50% target dose of beta-blockers Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81

  8. Patients and follow-up 7411 screened 6558 randomized 3268 to ivabradine 3290 to placebo Excluded: 26 Excluded: 27 3241 analysed 2 lost to follow-up 3264 analysed 1 lost to follow-up Median study duration: 22.9 months; maximum: 41.7 months Swedberg K, et al. Lancet. 2010;376(9744):875-885

  9. Baseline characteristics Swedberg K, et al. Lancet. 2010;376(9744):875-885

  10. Baseline characteristics Swedberg K, et al. Lancet. 2010;376(9744):875-885

  11. Chronic HF background treatment Patients (%) Ivabradine 100 91 91 90 89 90 84 Placebo 83 80 70 61 59 60 50 40 30 22 22 20 10 4 3 0 Beta-blockers ACEIs and/or Diuretics Aldosterone Digitalis ICD/CRT ARBs antagonists Swedberg K, et al. Lancet. 2010;376(9744):875-885

  12. 90 80 70 60 50 40 30 20 10 0 Background beta-blocker treatment Ivabradine Patients (%) 100 Placebo 89 89 56 56 26 26 At least 50% target daily dose Target daily dose BB at randomization Swedberg K, et al. Lancet. 2010;376(9744):875-885

  13. Background beta-blocker treatment Swedberg K, et al. Lancet. 2010;376(9744):875-885

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