Who is sponsoring PROTECTIN?

PROTECTIN is sponsored by University Hospital, Geneva.

What condition does PROTECTIN study?

PROTECTIN studies Myocardial Injury, Myocardial Ischemia.

What drugs are being tested in PROTECTIN?

Interventions: Ivabradine, Placebo.

What is the status of PROTECTIN?

PROTECTIN is currently COMPLETED.

Last reviewed 2022-03-02 · How we verify

PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery (PROTECTIN)

NCT04436016 PHASE4 COMPLETED

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.

Details

Lead sponsor	University Hospital, Geneva
Phase	PHASE4
Status	COMPLETED
Enrolment	78
Start date	Mon Oct 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Jan 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Myocardial Injury
Myocardial Ischemia

Interventions

Ivabradine
Placebo

Countries

Switzerland