Mirabegron for Postural Orthostatic Tachycardia Syndrome
(RAISE BP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Cedars-Sinai Medical Center
Must not be taking: CYP2D6 substrates
Disqualifiers: Heart failure, Stroke, Myocardial infarction, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The American Heart Association funds this study.
Will I have to stop taking my current medications?
The trial requires that you stop taking any experimental medications within 4 weeks of participation and any drugs that are CYP2D6 substrates, like midodrine. If you're on these medications, you may need to stop them before joining the trial.
How does the drug Mirabegron differ from other drugs for treating Postural Orthostatic Tachycardia Syndrome (POTS)?
Mirabegron is unique because it is primarily used to treat overactive bladder by relaxing the bladder muscle, whereas other drugs for POTS, like Ivabradine, work by directly affecting heart rate. This novel approach may offer a different mechanism of action for managing POTS symptoms.
12345Eligibility Criteria
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.Inclusion Criteria
I have fainting spells or near-fainting due to low blood pressure not improved by lifestyle changes.
I have a history of fainting or almost fainting.
I have had symptoms when standing for more than 3 months.
+4 more
Exclusion Criteria
I have a fast heart rate that is not due to sinus tachycardia.
I experienced slow heartbeats before getting a pacemaker.
I am 18 years old or older.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive mirabegron (either 25 mg or 50 mg) for 8 weeks to assess its effects on blood pressure, syncope, and other symptoms
8 weeks
1 visit (in-person) at baseline, 1 visit (in-person) after 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a video visit 12 weeks after starting treatment
4 weeks
1 visit (virtual)
Participant Groups
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.
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.
Mirabegron is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Myrbetriq for:
- Overactive bladder (OAB)
- Neurogenic detrusor overactivity (NDO)
🇪🇺 Approved in European Union as Mirabegron for:
- Overactive bladder (OAB)
- Neurogenic detrusor overactivity (NDO)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical CenterLead Sponsor
References
Cardiac neurotransmission imaging with 123I-meta-iodobenzylguanidine in postural tachycardia syndrome. [2017]Postural orthostatic tachycardia syndrome (POTS) is a disorder of orthostatic intolerance characterised by excessive tachycardia of unknown aetiology. Whether this condition involves abnormal cardiac sympathetic innervation or function remains elusive. Meta-iodobenzylguanidine (MIBG) resembles guanethidine and is a pharmacologically inactive analogue of norepinephrine, which is similarly metabolised in noradrenergic neurons. MIBG myocardial scintigraphy is used clinically to estimate local myocardial sympathetic nerve damage in some forms of heart disease and autonomic neuropathy. The objective of this study was to evaluate cardiac sympathetic innervation in patients with POTS.
Use of Ivabradine in Postural Orthostatic Tachycardia Syndrome. [2020]Postural orthostatic tachycardia syndrome (POTS) is characterized by inappropriate increase in heart rate on assuming upright position from a supine position without a necessary drop in blood pressure. Etiology of this condition is complex and multifactorial. Autonomic dysfunction,[1] hypovolemia,[2] hyper responsiveness of beta adrenergic receptors[3] with associated elevations of plasma norepinephrine levels have been implicated as underlying pathophysiologic mechanisms. Beta blockers have previously been used to treat this condition. Ivabradine which selectively inhibits If ion current in the sino atrial node, has been reported to be useful in patients with POTS.[4,5] We present one further such case of POTS successfully treated by Ivabradine.
Single centre experience of ivabradine in postural orthostatic tachycardia syndrome. [2021]Postural orthostatic tachycardia syndrome (POTS) is associated with tachycardia on orthostasis. Patients frequently report palpitations, presyncope, and fatigue. Conventional therapy is effective in less than 60%. Case reports suggest ivabradine (a selective sinus node blocker, with no effect on blood pressure) may alleviate POTS-related symptoms. This is a retrospective case-series.
Ivabradine in children with postural orthostatic tachycardia syndrome: a retrospective study. [2021]Ivabradine is a unique medication that reduces the intrinsic heart rate by specifically blocking the inward funny current that controls the pacemaker activity of the sinus node. We conducted a retrospective cohort study to assess the efficacy of ivabradine in children suffering from postural orthostatic tachycardia syndrome.
Treatment of inappropriate sinus tachycardia with ivabradine in a patient with postural orthostatic tachycardia syndrome and a dual chamber pacemaker. [2018]We present the case of a 44-year-old woman with postural orthostatic tachycardia syndrome (POTS) and a dual chamber pacemaker. The patient suffered from inappropriate sinus tachycardia that had been resistant to treatment with traditional rate-slowing medications. Ivabradine--the specific sinus node I(f) current inhibitor--was used to successfully lower the heart rate. The patient had no evidence of POTS on repeat autonomic function testing, and there was a corresponding symptomatic benefit. We propose that this class of drugs, the use of which is established as antianginals, should be considered in patients with resistant inappropriate sinus tachycardia.