Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass

NCT ID: NCT02096406

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-03-31

Brief Summary

Coronary artery disease is a leading cause of death, hospitalization, and health care costs in developed nations. Coronary revascularization with coronary artery bypass graft (CABG) surgery improves the long term survival in patients with diabetes and multi-vessel disease. Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce mortality and subsequent cardiac events in patients with coronary artery disease undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have suggested that pre-operative ACE administration is associated with an increased risk of post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies have failed to confirm these findings and further suggested ACE are associated with a reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal group required significantly fewer vasopressors during cardiopulmonary bypass but more intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs should be held or continued immediately prior to CABG surgery and a survey of cardiac surgeons suggests that current clinical practice is divided. This pilot study aims to establish the feasibility of the study design and to determine the frequency of clinical endpoints among patients who continue and discontinue ACE prior to cardiac surgery.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACE/ARB Continuation

ACE/ARB will be continued up to and including the morning of surgery.

Group Type: OTHER

ACE/ARB continuation

Intervention Type: DRUG

ACE/ARB will be taken the morning of surgery with a sip of water

ACE/ARB withdrawal

ACE/ARB will be discontinued medication 48 hours prior to surgery

Group Type: OTHER

ACE/ARB withdrawal

Intervention Type: DRUG

ACE/ARB will be stopped 48 hours prior to surgery

Interventions

ACE/ARB continuation

ACE/ARB will be taken the morning of surgery with a sip of water

Intervention Type: DRUG

ACE/ARB withdrawal

ACE/ARB will be stopped 48 hours prior to surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery
• On an ACE or ARB for a minimum of 7 days

Exclusion Criteria

• Emergency surgery
• Pre-operative shock (defined as systolic blood pressure < 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device)
• Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents)
• ACE or ARB therapy < 7 days
• Any mineralocorticoid receptor antagonist therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Sean van Diepen

Assistant Professor of Critical Care Medicine and Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean van Diepen, MD, Msc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

van Diepen S, Norris CM, Zheng Y, Nagendran J, Graham MM, Gaete Ortega D, Townsend DR, Ezekowitz JA, Bagshaw SM. Comparison of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Management Strategies Before Cardiac Surgery: A Pilot Randomized Controlled Registry Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009917. doi: 10.1161/JAHA.118.009917.

Reference Type: DERIVED

PMID: 30371293 (View on PubMed)

Other Identifiers

Pro00042749

Identifier Type: -

Identifier Source: org_study_id