A Phase 4 interventional study of metoprolol in Adrenergic Beta-Receptor Blockader, Troponin Levels and Cardiomyopathy, Post-surgical, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Prevention
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 70 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: metoprolol
Also known as: Lopressor
Difference in hscTnI Values
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Time frame: Before surgery and Immediately after surgery (on the day of surgery)
| Milestone | Treatment |
|---|---|
| Started | 70 |
| Completed | 20 |
| Not completed | 50 |
| Withdrew: Surgery cancelled or time chaned | 13 |
| Withdrew: Received epidural | 10 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Bradycardia/hypotension | 9 |
| Withdrew: Study paused | 8 |
| Withdrew: Put on beta-blocker | 3 |
| Withdrew: Type of surgery | 1 |
| Withdrew: Typ of surgery | 1 |
| Withdrew: Pi unavailable | 1 |
| Withdrew: Unknown history of cva | 1 |
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
| ng/L | Treatment |
|---|---|
| Preoperative visit | 3.4 (2.0 to 4.8) |
| Day of surgery | 2.8 (2.3 to 4.4) |
Collected over Day of surgery until postoperative day 3 or hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 13 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 9 |
| Male | 11 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 20 |
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Washington University School of Medicine