Metoprolol for Fainting

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Calgary

Must not be taking: Beta blockers

Disqualifiers: Asthma, Diabetes, COPD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 50 weeks

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Who Is on the Research Team?

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

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?

Group I: Metoprolol Active Control 1 Intervention

Metoprolol 50 mg po tablets will be provided for final dosing range (25 mg po BID to 100 mg po BID) for study duration (1 year). Patients will be started at 50 mg po BID and titrated over 2 weeks to target of 100 mg po BID.

Group II: Placebo Placebo Group 1 Intervention

Matching placebo will be identical in appearance to the active treatment pill. Patients will be started at 50 mg po BID and titrated over 2 weeks to target of 100 mg po BID.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The ongoing UNAMET study is evaluating the impact of metoprolol on quality of life and the incidence of adverse drug reactions (ADRs) in outpatients, using standard questionnaires over a 6-week period.

The study aims to determine if genotyping for the CYP2D6 enzyme can help guide initial dosing of metoprolol, particularly for patients who are poor metabolizers and may be at higher risk for ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rationale and methods of the UNAMET study (dose- and CYP2D6-genotype-dependent adverse drug reactions of metoprolol)--a contribution to quality improvement in pharmacotherapy]. Fux, R., Meisner, C., Schwab, M., et al.[2015]

In a randomized, placebo-controlled trial involving 208 patients with vasovagal syncope, metoprolol did not significantly reduce the risk of recurrent syncope compared to placebo over a 1-year treatment period.

The study found that neither the age of the patients nor their initial tilt-test results predicted any benefit from metoprolol, indicating that this beta-blocker is not effective for preventing vasovagal syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Syncope Trial (POST): a randomized, placebo-controlled study of metoprolol in the prevention of vasovagal syncope. Sheldon, R., Connolly, S., Rose, S., et al.[2022]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK532923/

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.

2.

hcplive.com

hcplive.com/view/august-2006-baggs

Metoprolol for the prevention of vasovagal syncope

Results showed little evidence that metoprolol was effective in reducing the burden of syncopal symptoms. In a substudy analysis, neither age nor response ...

3.

jacc.org

jacc.org/doi/10.1016/S0735-1097%2802%2901970-8

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, ...

4.

mayoclinic.org

mayoclinic.org/drugs-supplements/metoprolol-oral-route/description/drg-20071141

Metoprolol (oral route) - Side effects & dosage

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7306637/

Metoprolol-Associated Central Nervous System Complications

Metoprolol is a moderately lipophilic beta-blocker and if administered at clinical doses it has a low incidence of neuropsychiatric side effects.

6.

webmd.com

webmd.com/drugs/2/drug-8814-2372/metoprolol-succinate-oral/metoprolol-succinate-extended-release-capsule-oral/details

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 ...

7.

goodrx.com

goodrx.com/toprol-xl/toprol-xl-side-effects?srsltid=AfmBOoq5JwUwtjbN2LVAQ8Y6PbivV0NnZXpjhtuueIWOnvYpqboj2GyS

10 Toprol XL Side Effects You Should Know About

Toprol XL (metoprolol succinate) can cause diarrhea, mood changes, and low blood pressure in some people. Review the common and serious side effects here.

8.

drugs.com

drugs.com/sfx/metoprolol-side-effects.html

Metoprolol Side Effects: Common, Severe, Long Term

Metoprolol may worsen the symptoms of heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort.