Clinical trial NCT02096406: Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass
Official title: COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Coronary artery bypass grafting
angiotensin converting enzyme inhibitor
angiotensin receptor blocker
Surgical valve repair
Valve Replacement
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adherence to the study protocol
timeFrame: From randomization to surgery
measure: Feasibility of study enrollment
timeFrame: 30 dasys
measure: Feasibility of Study
timeFrame: 60 days
Secondary outcomes:
measure: Feasibility of the Study
timeFrame: 30 days
measure: Incidence of post operative Shock
timeFrame: 3 hours
measure: Duration of Shock
timeFrame: 7 days
measure: Vasopressors use
timeFrame: 7 days
measure: Post operative intravenous anti-hypertensive use
timeFrame: 7 days
measure: Duration of intravenous vasodilator use
timeFrame: 7 days
measure: Vasodilator use
timeFrame: 7 days
measure: Incidence of vasoplegic shock
timeFrame: 4 hours
measure: Pre-operative heart failure deterioration
timeFrame: 48 hours
measure: Post-operative acute kidney injury
timeFrame: 7 days
measure: Change in renal function
timeFrame: 7 days
measure: Initiation of renal replacement therapy
timeFrame: 7 days
measure: Peak post-operative troponin
timeFrame: 72 hours
measure: Stroke
timeFrame: 30 days
measure: In hospital Mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
measure: ACE or ARB use at hospital discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Duration of post-operative mechanical ventilation
timeFrame: 7 days
measure: Cardiovascular ICU length of stay
timeFrame: Participants will be followed for the duration of the ICU stay, an expected average of 2 days
measure: ICU readmission
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sean van Diepen, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.