Metoprolol for Fainting

Not currently recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Calgary
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether metoprolol, a common heart medication, can reduce fainting episodes in individuals who frequently experience vasovagal syncope (a type of fainting caused by a sudden drop in heart rate and blood pressure). The researchers aim to determine if metoprolol prevents these fainting spells more effectively than a placebo (a pill with no active medicine) in affected individuals. This study may suit people aged 40 and older who have experienced at least one fainting spell in the past year and have been diagnosed with vasovagal syncope. Those who often faint and find it disrupts daily life might find this trial a good fit. As a Phase 4 trial, metoprolol is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on beta blockers or antihypertensive medications, you might need to discuss this with the trial team, as certain conditions related to these medications are part of the exclusion criteria.

What is the safety track record for metoprolol?

Research has shown that metoprolol is generally safe for use. This medication often treats high blood pressure and other heart issues. Studies have found that metoprolol can lower the risk of death by 34% compared to a placebo over a year for certain heart conditions.

However, metoprolol can cause side effects. Common ones include dizziness, lightheadedness, or fainting, especially when standing up quickly. Other side effects might include fatigue, weakness, or mood changes. In some cases, it can cause low blood pressure or worsen heart failure symptoms, so monitoring by a doctor is important.

Overall, many patients tolerate metoprolol well, but discussing any concerns with a healthcare provider is advisable. They can help weigh the benefits against potential risks.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Metoprolol for treating fainting because it targets the heart's beta-receptors, potentially stabilizing heart rate and blood pressure more effectively than current treatments. Unlike standard options for fainting, which often focus on lifestyle changes or medications like fludrocortisone and midodrine, Metoprolol directly addresses the cardiovascular system's role in fainting. This direct approach could offer a more targeted solution, reducing symptoms and improving quality of life for those affected by frequent fainting episodes.

What evidence suggests that metoprolol might be an effective treatment for vasovagal syncope?

Research has shown that metoprolol, one of the treatments studied in this trial, may help reduce fainting in older adults. Studies have found that beta blockers like metoprolol can prevent fainting in this age group. A detailed review of several studies found that metoprolol significantly lowered the risk of fainting, with a hazard ratio of 0.52, indicating a reduced chance of fainting. The review also noted that metoprolol might be more effective for individuals aged 42 and older. While some studies found limited evidence of metoprolol's overall effectiveness in reducing fainting symptoms, the age-specific benefits suggest it could be valuable for older patients. Participants in this trial will receive either metoprolol or a matching placebo to further evaluate its effectiveness.13678

Who Is on the Research Team?

Robert S. Sheldon - Professor, Alberta ...

Robert S Sheldon, MD, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for people aged 40 or older who have had at least one fainting episode in the past year and score above a certain threshold on a syncope symptom score. It's not suitable for those with structural heart abnormalities.

Inclusion Criteria

I am 40 years old or older.
≥-2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
I have fainted at least once in the past year.

Exclusion Criteria

Major chronic non-cardiovascular disease
An implanted defibrillator
Known hypersensitivity to metoprolol and derivatives
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Titration

Participants receive an initial dose of 50 mg BID of metoprolol or placebo, titrated over 2 weeks to a target of 100 mg BID

2 weeks

Treatment

Participants continue receiving metoprolol or placebo for the remainder of the 1-year observation period

50 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Matching Placebo
  • Metoprolol
Trial Overview The study tests if Metoprolol, a beta blocker, can prevent fainting episodes better than a placebo in older adults with frequent vasovagal syncope. Participants will be randomly assigned to receive either Metoprolol or placebo.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: MetoprololActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Vanderbilt University

Collaborator

Trials
714
Recruited
6,143,000+

Published Research Related to This Trial

Metoprolol, particularly in its controlled release (CR/XL) form, has been shown to significantly lower mortality rates in patients with chronic heart failure compared to other forms, such as immediate release (IR) and sustained release (SR).
While metoprolol SR does not demonstrate superior antihypertensive efficacy compared to IR or CR/XL, the new controlled release formulation (CD/ERT) has been proven bioequivalent to CR/XL, suggesting it may offer similar benefits in managing heart conditions.
[Evolution of oral drug forms of metoprolol: advantages of long acting modified release forms with modified release].Leonova, MV., Maneshina, OA., Belousov, IuB.[2017]
In a study of 60 patients over 6 months, metoprolol succinate was found to be safe and well tolerated, with no significant differences in quality of life or withdrawal rates compared to placebo.
Patients taking metoprolol succinate experienced a significant increase in left ventricular ejection fraction and a reduction in ventricular ectopic beats, indicating improved heart function and rhythm stability.
Metoprolol CR/XL in patients with heart failure: A pilot study examining the tolerability, safety, and effect on left ventricular ejection fraction.Goldstein, S., Kennedy, HL., Hall, C., et al.[2019]
Metoprolol is an effective treatment for mild to moderate hypertension and angina pectoris, showing comparable efficacy to other medications like beta-blockers and diuretics, and can be administered in both twice-daily and once-daily doses.
While metoprolol has shown some benefits in reducing mortality in post-myocardial infarction patients over a longer term, its use during the acute phase of myocardial infarction remains controversial due to mixed results in mortality reduction.
Metoprolol. An updated review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy, in hypertension, ischaemic heart disease and related cardiovascular disorders.Benfield, P., Clissold, SP., Brogden, RN.[2018]

Citations

Metoprolol - StatPearls - NCBI Bookshelf[4] The results showed that metoprolol succinate reduced the risk of death by 34% compared with placebo over a mean follow-up of 1 year.
Metoprolol for the prevention of vasovagal syncopeResults showed little evidence that metoprolol was effective in reducing the burden of syncopal symptoms. In a substudy analysis, neither age nor response ...
Dose of metoprolol CR/XL and clinical outcomes in ...Data indicated somewhat higher risk in the low-dose group compared with the high-dose group. Heart rate was reduced to a similar degree in the two dose groups, ...
Metoprolol (oral route) - Side effects & dosageDizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help ...
Metoprolol-Associated Central Nervous System ComplicationsMetoprolol is a moderately lipophilic beta-blocker and if administered at clinical doses it has a low incidence of neuropsychiatric side effects.
Metoprolol (Lopressor, Toprol XL, others) - Uses, Side ...What are the serious side effects of metoprolol? · Feeling lightheaded, dizziness, or fainting · Confusion · Feeling weak or easily tired · Chest ...
10 Toprol XL Side Effects You Should Know AboutToprol XL (metoprolol succinate) can cause diarrhea, mood changes, and low blood pressure in some people. Review the common and serious side effects here.
Metoprolol Side Effects: Common, Severe, Long TermMetoprolol may worsen the symptoms of heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort.
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