PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery
Status:
Recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
Perioperative myocardial injury (PMI) after non-cardiac surgery (NCS), i.e. the elevation of
postoperative troponin, occurs in nearly 20% of patients older than 45 years undergoing NCS
and is independently and strongly associated with post-operative mortality (30-day mortality
up to 10%). With over 300 million surgical interventions every year worldwide, PMI has a high
clinical relevance on the health of the population.
Heart rate (HR) is an independent and modifiable risk factor for PMI and death after
non-cardiac surgery. Numerous studies showed that beta-blockers decrease myocardial ischemia
after surgery in a heart-rate dependent manner, but this beneficial effect is surpassed by an
increased incidence of perioperative hypotension and death. Currently, no single intervention
is available to decrease the risk of perioperative cardiac complications. Ivabradine (IVA) is
a negative chronotropic agent without significant effects on contractility or vascular tone
and has been shown to improve outcomes in the setting of chronic and acute heart diseases.
Rationale for pilot feasibility trial: the planned definitive large trial is a multicenter
trial to investigate the efficacy of ivabradine to decrease perioperative myocardial injury.
The intervention planned is complex and demands important resources. The investigators
designed this pilot study to inform on the feasibility of the definitive large trial. This
pilot study will also provide additional information that could help investigators improve
the definitive large trial regarding recruitment, refinements to the study protocol and
improving the participant's experience.