HypertensionPASSNCT01091961
Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications
A study testing Preoperative ACEi/ARB management in people with Hypertension, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Preoperative ACEi/ARB management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently taking an ACEi, ARB or both
- no change in these medications during the two weeks prior to study enrollment
- scheduled for non-cardiac surgery requiring regional or general anesthesia
- minimum overnight anticipated length of stay
- age ≥18 years.
Who cannot join
- explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
- significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
- significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg)
- prior enrollment in the study
- participation in another research study of antihypertensive medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Operative Inhibition of the Angiotensin System Study: A Prospective Randomized Single-Blinded Trial of Pre-Operative Management of Medications That Inhibit the Renin-Angiotensin System
Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.
- Conditions
- Hypertension
- Being tested
- Preoperative ACEi/ARB management
- Keywords
- ACE inhibitor, ARB, Non-cardiac surgery, Perioperative, Preoperative, Hypotension, Congestive heart failure, Hypertension, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Type 1 Receptor Blockers, Perioperative Care
- Medical subject headings
- Hypertension, Hypotension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative ACEi/ARB managementProcedure or surgery
Patients will either hold their chronic ACEi/ARB medication for at least 24 hours prior to surgery, or continue to take the ACEi/ARB medication up to and including the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Continuing ACEi/ARB | Active comparator | Patients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery. Receives: Procedure: Preoperative ACEi/ARB management |
| Holding ACEi/ARB | Active comparator | Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery. Receives: Procedure: Preoperative ACEi/ARB management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure
Measured: 24 hours after surgery
Secondary outcomes (4)
Clinically significant hypotension
Measured: 30 days after surgery
Clinically significant hypertension
Measured: 30 days after surgery
All-cause mortality
Measured: 30 days after surgery
Cardiovascular morbidity
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marko Mrkobrada, MD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091961
- Sponsor's protocol ID
- R-09-487
- Other IDs
- 16503
- Acronym
- PASS
- Status last verified
- Oct 2021
- First submitted
- 22 Mar 2010
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Inhibition of the Angiotensin System Study: A Prospective Randomized Single-Blinded Trial of Pre-Operative Management of Medications That Inhibit the Renin-Angiotensin System
- ClinicalTrials.gov ID
- NCT01091961
- Acronym / sponsor ID
- PASS / R-09-487
- Conditions
- Hypertension
- Keywords
- ACE inhibitor, ARB, Non-cardiac surgery, Perioperative, Preoperative, Hypotension, Congestive heart failure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuing ACEi/ARB | Active comparator | Procedure: Preoperative ACEi/ARB managementPatients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery. |
| Holding ACEi/ARB | Active comparator | Procedure: Preoperative ACEi/ARB managementPatients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- currently taking an ACEi, ARB or both
- no change in these medications during the two weeks prior to study enrollment
- scheduled for non-cardiac surgery requiring regional or general anesthesia
- minimum overnight anticipated length of stay
- age ≥18 years.
Key exclusion criteria (5 listed)
- explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
- significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
- significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg)
- prior enrollment in the study
- participation in another research study of antihypertensive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative ACEi/ARB managementPatients will either hold their chronic ACEi/ARB medication for at least 24 hours prior to surgery, or continue to take the ACEi/ARB medication up to and including the day of surgery | Procedure or surgery | Continuing ACEi/ARB, Holding ACEi/ARB |
Primary outcome
Mean arterial blood pressure
Time frame: 24 hours after surgery
4 secondary outcomes
Clinically significant hypotension
Time frame: 30 days after surgery
Clinically significant hypertension
Time frame: 30 days after surgery
All-cause mortality
Time frame: 30 days after surgery
Cardiovascular morbidity
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Mrkobrada, MD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative ACEi/ARB management in people with Hypertension, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.