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Mirabegron for Postural Orthostatic Tachycardia Syndrome (RAISE BP Trial)

Phase 2

Recruiting

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy

A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

RAISE BP Trial Summary

This trial tests if a drug can improve BP, syncope, QOL, chest pain, and OAB in POTS patients, funded by the American Heart Association.

Who is the study for?

This trial is for adults over 18 with Postural Orthostatic Tachycardia Syndrome (POTS) who often feel faint or have rapid heartbeats due to low blood pressure and haven't found relief with standard treatments. It's not for those allergic to Mirabegron, pregnant, breastfeeding, with severe kidney issues, certain heart conditions, recent stroke or heart attack, active thyroid problems, or taking specific drugs.Check my eligibility

What is being tested?

The study tests if Mirabegron can help raise blood pressure and improve life quality in POTS patients by preventing fainting spells and reducing chest pain and bladder symptoms. Two doses of Mirabegron (25 MG & 50 MG) are being compared to find the most effective one.See study design

What are the potential side effects?

Mirabegron may cause increased blood pressure, urinary tract infections (UTI), headaches, dizziness, nausea, diarrhea constipation or joint pain. Some people might also experience a fast heartbeat.

RAISE BP Trial Eligibility Criteria

Inclusion Criteria

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

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I have fainting spells or near-fainting due to low blood pressure not improved by lifestyle changes.

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I have a history of fainting or almost fainting.

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I am older than 18 years.

RAISE BP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood Pressure

Secondary outcome measures

Duke Activity Status Index Questionnaire

EQ-5D-5L Questionnaire

Hypotensive episode

+3 more

RAISE BP Trial Design

2Treatment groups

Active Control

Group I: 25 mg groupActive Control1 Intervention

Ten patients will receive 25 mg mirabegron for 8 weeks.

Group II: 50 mg groupActive Control1 Intervention

Ten patients will receive 50 mg mirabegron for 8 weeks.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,843 Total Patients Enrolled

Frequently Asked Questions

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

Are any new participants being sought for this clinical experiment?

"As noted in clinicaltrials.gov, this particular medical trial is not currently recruiting participants. The study was published on the 22nd of November 2023 and last updated on the 14th of that same month. However, there are 1,642 other trials actively searching for volunteers at present time."

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