Ivabradine and outcomes in chronic heart failure (SHIFT): a
randomised placebo-controlled study

J 2010

Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study

SWEDBERG, K, M KOMAJDA, M BOHM, JS BORER, I FORD et. al.

Basic information

Original name

Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study

Authors

SWEDBERG, K, M KOMAJDA, M BOHM, JS BORER, I FORD, A DUBOST-BRAMA, G LEREBOURS and L TAVAZZI

Edition

Lancet, NEW YORK, ELSEVIER SCIENCE INC, 2010, 0140-6736

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 33.633

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/S0140-6736(10)61198-1

UT WoS

000282069100028

Změněno: 23/2/2015 15:31, Ing. Mgr. Věra Pospíšilíková

Abstract

V originále

Background Chronic heart failure is associated with high mortality and morbidity. Raised resting heart rate is a risk factor for adverse outcomes. We aimed to assess the effect of heart-rate reduction by the selective sinus-node inhibitor ivabradine on outcomes in heart failure. Methods Patients were eligible for participation in this randomised, double-blind, placebo-controlled, parallel-group study if they had symptomatic heart failure and a left-ventricular ejection fraction of 35% or lower, were in sinus rhythm with heart rate 70 beats per min or higher, had been admitted to hospital for heart failure within the previous year, and were on stable background treatment including a beta blocker if tolerated. Patients were randomly assigned by computer-generated allocation schedule to ivabradine titrated to a maximum of 7.5 mg twice daily or matching placebo. Patients and investigators were masked to treatment allocation. The primary endpoint was the composite of cardiovascular death or hospital admission for worsening heart failure. Analysis was by intention to treat. This trial is registered, number ISRCTN70429960. Findings 6558 patients were randomly assigned to treatment groups (3268 ivabradine, 3290 placebo). Data were available for analysis for 3241 patients in the ivabradine group and 3264 patients allocated placebo. Median follow-up was 22.9 (IQR 18-28) months. 793 (24%) patients in the ivabradine group and 937 (29%) of those taking placebo had a primary endpoint event (HR 0.82, 95% CI 0.75-0.90, p<0.0001). The effects were driven mainly by hospital admissions for worsening heart failure (672 [21%] placebo vs 514 [16%] ivabradine; HR 0.74, 0.66-0.83; p<0.0001) and deaths due to heart failure (151 [5%] vs 113 [3%]; HR 0.74, 0.58-0.94, p=0.014). Fewer serious adverse events occurred in the ivabradine group (3388 events) than in the placebo group (3847; p=0.025). 150 (5%) of ivabradine patients had symptomatic bradycardia compared with 32 (1%) of the placebo group (p<0.0001). Visual side-effects (phosphenes) were reported by 89 (3%) of patients on ivabradine and 17 (1%) on placebo (p<0.0001). Interpretation Our results support the importance of heart-rate reduction with ivabradine for improvement of clinical outcomes in heart failure and confirm the important role of heart rate in the pathophysiology of this disorder.

Citovat

SWEDBERG, K, M KOMAJDA, M BOHM, JS BORER, I FORD, A DUBOST-BRAMA, G LEREBOURS and L TAVAZZI. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. NEW YORK: ELSEVIER SCIENCE INC, 2010, vol. 376, No 9744, p. 875-885. ISSN 0140-6736. Available from: https://dx.doi.org/10.1016/S0140-6736(10)61198-1.

@article{1227626,
   author = {Swedberg, K and Komajda, M and Bohm, M and Borer, JS and Ford, I and DubostandBrama, A and Lerebours, G and Tavazzi, L and Siegelová, Jarmila and Špinar, Jindřich and Špinarová, Lenka},
   article_location = {NEW YORK},
   article_number = {9744},
   doi = {http://dx.doi.org/10.1016/S0140-6736(10)61198-1},
   language = {eng},
   issn = {0140-6736},
   journal = {Lancet},
   note = {Paní prof. Siegelová, paní prof. Špinarová a pan prof. Špinar vyjmenováni jako jedni z "Investigators" z ČR. Do is.muni zaevidováno na základě žádosti pana prof. Dobšáka.},
   title = {Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study},
   volume = {376},
   year = {2010}
}

TY  - JOUR
ID  - 1227626
AU  - Swedberg, K - Komajda, M - Bohm, M - Borer, JS - Ford, I - Dubost-Brama, A - Lerebours, G - Tavazzi, L - Siegelová, Jarmila - Špinar, Jindřich - Špinarová, Lenka
PY  - 2010
TI  - Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study
JF  - Lancet
VL  - 376
IS  - 9744
SP  - 875-885
EP  - 875-885
PB  - ELSEVIER SCIENCE INC
SN  - 01406736
N1  - Paní prof. Siegelová, paní prof. Špinarová a pan prof. Špinar vyjmenováni jako jedni z "Investigators" z ČR. Do is.muni zaevidováno na základě žádosti pana prof. Dobšáka.
N2  - Background Chronic heart failure is associated with high mortality and morbidity. Raised resting heart rate is a risk factor for adverse outcomes. We aimed to assess the effect of heart-rate reduction by the selective sinus-node inhibitor ivabradine on outcomes in heart failure. Methods Patients were eligible for participation in this randomised, double-blind, placebo-controlled, parallel-group study if they had symptomatic heart failure and a left-ventricular ejection fraction of 35% or lower, were in sinus rhythm with heart rate 70 beats per min or higher, had been admitted to hospital for heart failure within the previous year, and were on stable background treatment including a beta blocker if tolerated. Patients were randomly assigned by computer-generated allocation schedule to ivabradine titrated to a maximum of 7.5 mg twice daily or matching placebo. Patients and investigators were masked to treatment allocation. The primary endpoint was the composite of cardiovascular death or hospital admission for worsening heart failure. Analysis was by intention to treat. This trial is registered, number ISRCTN70429960. Findings 6558 patients were randomly assigned to treatment groups (3268 ivabradine, 3290 placebo). Data were available for analysis for 3241 patients in the ivabradine group and 3264 patients allocated placebo. Median follow-up was 22.9 (IQR 18-28) months. 793 (24%) patients in the ivabradine group and 937 (29%) of those taking placebo had a primary endpoint event (HR 0.82, 95% CI 0.75-0.90, p<0.0001). The effects were driven mainly by hospital admissions for worsening heart failure (672 [21%] placebo vs 514 [16%] ivabradine; HR 0.74, 0.66-0.83; p<0.0001) and deaths due to heart failure (151 [5%] vs 113 [3%]; HR 0.74, 0.58-0.94, p=0.014). Fewer serious adverse events occurred in the ivabradine group (3388 events) than in the placebo group (3847; p=0.025). 150 (5%) of ivabradine patients had symptomatic bradycardia compared with 32 (1%) of the placebo group (p<0.0001). Visual side-effects (phosphenes) were reported by 89 (3%) of patients on ivabradine and 17 (1%) on placebo (p<0.0001). Interpretation Our results support the importance of heart-rate reduction with ivabradine for improvement of clinical outcomes in heart failure and confirm the important role of heart rate in the pathophysiology of this disorder.
ER  -

SWEDBERG, K, M KOMAJDA, M BOHM, JS BORER, I FORD, A DUBOST-BRAMA, G LEREBOURS and L TAVAZZI. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. \textit{Lancet}. NEW YORK: ELSEVIER SCIENCE INC, 2010, vol.~376, No~9744, p.~875-885. ISSN~0140-6736. Available from: https://dx.doi.org/10.1016/S0140-6736(10)61198-1.

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