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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 1 year
Awards & highlights

POST 4 Trial Summary

This trial will test whether midodrine prevents fainting in people with a history of fainting.

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.Check my eligibility
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.See study design
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.

POST 4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure will be the proportion of patients having at least one syncope recurrence.
Secondary outcome measures
A is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).
A will be quality of life as measured by the EQ-5D and the ISQL.
A will be the frequency of syncopal spells.
+1 more

POST 4 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: midodrine hydrochloride pillsActive Control1 Intervention
Group II: oral placebo or sugar pillPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

Dr. Bob SheldonLead Sponsor
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,143,213 Total Patients Enrolled
1 Trials studying Vasovagal Syncope
52 Patients Enrolled for Vasovagal Syncope

Media Library

Midodrine Hydrochloride (Alpha-1 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01456481 — Phase 4
Vasovagal Syncope Research Study Groups: midodrine hydrochloride pills, oral placebo or sugar pill
Vasovagal Syncope Clinical Trial 2023: Midodrine Hydrochloride Highlights & Side Effects. Trial Name: NCT01456481 — Phase 4
Midodrine Hydrochloride (Alpha-1 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01456481 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with midodrine hydrochloride consumption?

"The safety level of midodrine hydrochloride pills was rated 3, as it is an approved medication and has gone through Phase 4 clinical trials."

Answered by AI

How widely distributed are the trials of this treatment across North America?

"Alberta Health Services - Royal Alexandra Hospital in Edmonton, Red Deer Regional Hospital in Red Deer and University of Ottawa Heart Institute in Ottawa are three sites running this clinical trial. Additionally, there are 16 other Canadian medical centres involved."

Answered by AI

Are there any antecedent studies that have assessed midodrine hydrochloride tablets?

"Midodrine hydrochloride pills were first investigated in 1997 by the Autonomic Dysfunction Center at Vanderbilt University. Since then, 49 clinical trials have concluded and presently there are 13 active research projects with several based out of Edmonton, Alberta."

Answered by AI

Is enrollment for this research endeavor still available?

"Unfortunately, no further participants are being accepted for this trial. Initially posted on November 1st 2011 and last edited on November 1st 2022, it has been ended. However, there are presently 25 clinical trials actively recruiting synocpe patients and 13 studies employing midodrine hydrochloride that require volunteers."

Answered by AI

How many individuals are the maximum capacity of this experiment?

"At the moment, this particular research project is not actively recruiting participants. It was first publicly listed on November 1st 2011 and its most recent update occurred on November 1st 2022. If you are looking for other studies related to syncope, there are currently 25 trials that have open enrolment and 13 assessing midodrine hydrochloride tablets in need of volunteers."

Answered by AI
~10 spots leftby Apr 2025