← Back to Search

Metoprolol for Fainting

Phase 4

Waitlist Available

Led By Robert S Sheldon, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥1 syncopal spells in the year preceding enrollment

Age ≥ 40 years

Must not have

Resting heart rate <50 bpm or supine systolic blood pressure <90 mm Hg in the absence of beta blockers or antihypertensive medications

Hypertrophic cardiomyopathy or known or probable genetic arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial will determine if metoprolol can prevent fainting in people with vasovagal syncope, aged 40 and up.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Metoprolol may cause side effects such as tiredness, dizziness, cold hands and feet, upset stomach, or shortness of breath. However, individual reactions to the medication can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have fainted at least once in the past year.

Select...

I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My resting heart rate is below 50 bpm or my blood pressure is below 90/60 without medication.

Select...

I have a thickened heart muscle or a genetic heart rhythm problem.

Select...

I am unable to understand and agree to the study's details on my own.

Select...

I have a significant heart valve, artery, muscle, or rhythm problem.

Select...

I have a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MetoprololActive Control1 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: PlaceboPlacebo Group1 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.

0 / 7Eligibility criteria met