Midodrine for Fainting

(POST 4 Trial)

Not currently recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dr. Bob Sheldon

Disqualifiers: Hypertension, Seizure disorder, Hepatic disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether Midodrine can prevent fainting spells in individuals with moderate to severe vasovagal syncope, a condition characterized by frequent fainting due to a sudden drop in heart rate and blood pressure. Midodrine may help by raising blood pressure. Participants will receive either Midodrine or a placebo (a sugar pill with no active ingredients) to compare outcomes. Individuals who have fainted at least twice in the past year and have a structurally normal heart are suitable candidates for this trial. As a Phase 4 trial, Midodrine is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Midodrine Hydrochloride?

Research has shown that Midodrine Hydrochloride can help with certain conditions, but it may cause side effects. Common side effects include tingling, itching, and increased blood pressure. Dizziness or a slower heartbeat may also occur. These usually don't require medical attention, but monitoring them is important. In rare cases, it can cause fainting or heightened awareness of your heartbeat. The FDA has approved Midodrine for other uses, suggesting general safety, but caution is still advised. Always consult your doctor to understand how it might affect you personally. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Midodrine hydrochloride is unique because it specifically targets the body's blood vessels to increase blood pressure, helping prevent fainting episodes. Unlike other treatments for fainting, which often focus on lifestyle changes or general medications to increase blood volume, midodrine works by constricting blood vessels, providing a more direct mechanism to maintain blood pressure. Researchers are excited about midodrine because it may offer a faster and more targeted approach, potentially reducing the frequency of fainting spells more effectively than current options.

What evidence suggests that Midodrine might be an effective treatment for fainting?

Research has shown that Midodrine, which participants in this trial may receive, can help prevent fainting, particularly in individuals with vasovagal syncope. This condition causes sudden drops in blood pressure and heart rate, leading to fainting. Studies have found that Midodrine reduces fainting episodes during tilt-table tests, which safely trigger fainting in a controlled environment. Midodrine raises blood pressure and helps more blood return to the heart. One study found it effective for older adults with fainting problems over two years. Midodrine is already known to help with low blood pressure when standing, supporting its potential use for preventing fainting. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have fainted two or more times in the year before joining the study.

You have a syncope symptom score of -2 or higher for structurally normal hearts.

Exclusion Criteria

You have medical conditions that can cause fainting, like heart rhythm problems or low blood pressure when standing up.

You have trouble peeing.

Patients with an inability to give informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either midodrine hydrochloride or a placebo to test its effectiveness in preventing vasovagal syncope

12 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
• Midodrine Hydrochloride

Trial Overview 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.

How Is the Trial Designed?

Group I: midodrine hydrochloride pills Active Control 1 Intervention

Group II: oral placebo or sugar pill Placebo Group 2 Interventions

Midodrine Hydrochloride is already approved in United States, European Union, Canada for the following indications:

Approved in United States as ProAmatine for:

• Orthostatic hypotension

Approved in European Union as Orvaten for:

• Orthostatic hypotension

Approved in Canada as Midodrine Hydrochloride for:

• Orthostatic hypotension

Who Is Running the Clinical Trial?

Dr. Bob Sheldon

Lead Sponsor

Trials

1

Recruited

130+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9301979/

Midodrine for the prevention of vasovagal syncope Midodrine is effective in preventing syncope induced by HUT testing and less, but still significant, RR reduction in randomized, double-blinded clinical trials.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01456481

Study Details | NCT01456481 | Assessment of Midodrine in ... The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878764912001131

Midodrine hydrochloride in the management of older adults ... Our prospective observational study suggests that midodrine may be effective in older patients with NCS over a monitoring period extending beyond 2 years; with ...

4. academic.oup.com academic.oup.com/europace/article/13/11/1639/1746438

Effectiveness of Midodrine treatment in patients with recurrent ... Our findings indicate that additional Midodrine treatment is less effective in patients with VVS not responding to non-pharmacological treatment than reported ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4951503/

Clinical benefit of midodrine hydrochloride in symptomatic ... Midodrine is a well-tolerated and clinically effective treatment for symptomatic orthostatic hypotension.

6. mayoclinic.org mayoclinic.org/drugs-supplements/midodrine-oral-route/description/drg-20064821

Midodrine (oral route) - Side effects & dosage Fainting; increased dizziness; slow pulse. Some side effects may occur that usually do not need medical attention. These side effects may go ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/019815s010lbl.pdf

ProAmatine (midodrine hydrochloride) Tablets Warning dizziness, syncope, cardiac awareness) should be advised to discontinue ProAmatine. ® and should be re-evaluated. ProAmatine. ® should be used cautiously in ...

8. webmd.com webmd.com/drugs/2/drug-14042/midodrine-oral/details

Midodrine (Orvaten, ProAmatine): Uses, Side Effects ... Common side effects include tingling, itching, and high blood pressure. The main serious side effect is high blood pressure, particularly upon ...

9. drugs.com drugs.com/sfx/midodrine-side-effects.html

Midodrine Side Effects: Common, Severe, Long Term More common side effects. blurred vision; cardiac awareness; headache · Rare side effects. fainting; increased dizziness; slow pulse · More common ...

10. goodrx.com goodrx.com/midodrine/what-is?srsltid=AfmBOopPmHdWUblUrZ1IhWxNzxPLfWMZAM172JA2TCJFmmvd4ZjdT1lH

Midodrine (Proamatine): Uses, Side Effects, Interactions & ... Midodrine can cause side effects like tingling or pricking feeling and goosebumps. Midodrine is available as a generic; there's no brand-name version of this ...