What is the mechanism of action of this treatment?

Midodrine, an alpha-1 adrenergic agonist, is a common treatment for Vasovagal Syncope. It increases venous return to the heart and raises blood pressure, which helps prevent the sudden drop in blood pressure that leads to fainting. This mechanism is crucial for Vasovagal Syncope patients as it stabilizes blood pressure, reducing the frequency and severity of syncope episodes and improving their quality of life.

What side effects are associated with this type of intervention?

Midodrine, an alpha-1 adrenergic agonist used for treating vasovagal syncope, commonly causes side effects such as piloerection, pruritus, paresthesia, and urinary retention. Additionally, it can lead to supine hypertension, requiring careful monitoring to manage this risk effectively.

What prior FDA approvals exist?

There are no therapies for vasovagal syncope that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine, an alpha-1 adrenergic agonist, is being studied for its potential to prevent recurrences of syncope in patients with moderate to severe vasovagal syncope. However, it is not explicitly mentioned as FDA-approved for this specific indication.

What other types of research exist?

As of 2024, promising novel alternatives to Midodrine for Vasovagal Syncope include Fludrocortisone, which helps increase blood volume and blood pressure, and Droxidopa, a norepinephrine precursor that can improve blood pressure. Both have shown potential in clinical trials for managing symptoms of vasovagal syncope.

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Alpha-1 Adrenergic Agonist

Midodrine for Fainting (POST 4 Trial)

Phase 4

Waitlist Available

Research Sponsored by Dr. Bob Sheldon

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Approved for 5 Other Conditions

Drug Has Already Been Approved

All Individual Drugs Already Approved

Summary

This trial tests whether Midodrine can prevent frequent fainting in adults by increasing blood pressure through tightening blood vessels. Midodrine has been shown to be effective in treating low blood pressure in various populations, including those with nervous system issues and spinal cord injuries.

Who is the study for?

This trial is for adults who have fainted at least twice in the past year and score ≥ -2 on a specific fainting symptom scale. They must be over 18, able to consent, and not have other causes of fainting like heart issues or seizures, nor conditions like urinary retention, liver disease, glaucoma, or uncontrolled high blood pressure.

What is being tested?

The study is testing if Midodrine can prevent fainting in people with frequent vasovagal syncope (a common cause of fainting). Participants will either receive Midodrine or a placebo without knowing which one they're getting to compare the effects fairly.

What are the potential side effects?

Midodrine may increase blood pressure by tightening blood vessels. Potential side effects could include scalp tingling, itching skin bumps (goosebumps), nausea, digestive issues, urinary problems due to its effect on muscles controlling bladder function.

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

Pivotal Trial

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

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

All Individual Drugs Already Approved

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: midodrine hydrochloride pillsActive Control1 Intervention

Group II: oral placebo or sugar pillPlacebo Group2 Interventions

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Midodrine, an alpha-1 adrenergic agonist, is a common treatment for Vasovagal Syncope. It increases venous return to the heart and raises blood pressure, which helps prevent the sudden drop in blood pressure that leads to fainting. This mechanism is crucial for Vasovagal Syncope patients as it stabilizes blood pressure, reducing the frequency and severity of syncope episodes and improving their quality of life.

Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial.