Adrenergic Beta-Receptor BlockaderPhase 4NCT02746575
Pilot - Peri-operative Beta Blockade
A Phase 4 study testing metoprolol in people with Adrenergic Beta-Receptor Blockader and Troponin Levels, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Perioperative cardiac adverse events [heart injuries caused by general anesthesia and surgical procedures] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Adrenergic Beta-Receptor Blockader, Troponin Levels, Cardiomyopathy, Post-surgical
- What is being tested?
- metoprolol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years
- American Society of Anesthesiologists (ASA) risk status III-IV
- Revised Cardiac Risk Index ≥2
- β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
- Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
- History of peripheral vascular disease, or
Show all 9Show fewer
- Diabetes and currently on oral anti-diabetic drug or insulin therapy, or
- Chronic renal failure (eGFR <30 m/min)
- Major non-cardiac surgery under general anesthesia
Who cannot join
- History of stroke
- Heart rate <55bpm
- Heart failure
- Second or third degree AV block without pacemaker
- Active asthma or COPD
- Anemia [Hb<9g/dL]
Show all 10Show fewer
- Allergy to beta-blockade drugs
- Hemodynamic instability
- Uncontrolled hemorrhage
- Unwilling or unable to give consent for participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study
Perioperative cardiac adverse events [heart injuries caused by general anesthesia and surgical procedures] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.
- Being tested
- metoprolol
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoprololDrug
Also called Lopressor
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours. Receives: Drug: metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in hscTnI Values
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Measured: Before surgery and Immediately after surgery (on the day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adrenergic Beta-Receptor BlockaderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746575
- Sponsor's protocol ID
- 201507010
- Status last verified
- Jan 2020
- First submitted
- 14 Apr 2016
- Last updated
- 30 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study
- ClinicalTrials.gov ID
- NCT02746575
- Acronym / sponsor ID
- 201507010
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 30 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative cardiac adverse events [heart injuries caused by general anesthesia and surgical procedures] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: metoprololPostsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours. |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >50 years
- American Society of Anesthesiologists (ASA) risk status III-IV
- Revised Cardiac Risk Index ≥2
- β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
- Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
Key exclusion criteria (10 listed)
- History of stroke
- Heart rate <55bpm
- Heart failure
- Second or third degree AV block without pacemaker
- Active asthma or COPD
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 |
|---|---|---|
| metoprololAlso: Lopressor | Drug | treatment |
Primary outcome
Difference in hscTnI Values
Time frame: Before surgery and Immediately after surgery (on the day of surgery)
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metoprolol in people with Adrenergic Beta-Receptor Blockader and Troponin Levels, run by Washington University School of Medicine at 1 site in United States.
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 9 inclusion and 10 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 30 Jan 2020. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in hscTnI Values (time frame: Before surgery and Immediately after surgery (on the day of 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 30 Jan 2020.