Beta-3 Enhanced Autonomic Therapy for POTS (BEAT-POTS)
9. mai 2026 oppdatert av: Peng-Sheng Chen, Cedars-Sinai Medical Center
A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms
The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
Participants will undergo 4 weeks of randomized treatment, with an optional 4-week extension, and a final safety follow-up visit 4 weeks after discontinuation (total participation up to 12 weeks).
The investigators will perform skin sympathetic nerve activity (SKNA) recordings and assess self-reported symptom frequencies using the number of pushbutton events per day.
The patients will also record symptoms in a daily diary.
The investigators will assess quality of life (QOL) and overactive bladder (OAB) symptoms using validated questionnaires at baseline and after mirabegron treatment.
The investigators will repeat the QOL questionnaires at 4 weeks and 8 weeks in those who choose to extend therapy.
Studietype
Intervensjonell
Registrering (Antatt)
36
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Peng-Sheng Chen, MD
- Telefonnummer: 310-967-2707
- E-post: peng-sheng.chen@csmc.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Provision of a signed and dated informed consent form.
- Male or female, age ≥ 18 years old.
- Confirmed POTS diagnosis, which includes chronic (>3 months) orthostatic intolerance, an increase in heart rate (HR) of ≥30 beats per minute (bpm) without orthostatic hypotension (>20 mmHg drop of systolic BP) during orthostatic tests.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
- Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization)
- Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18
- Active thyrotoxicosis
- Any experimental medication concomitantly or within 4 weeks of participation in the study
- Currently participating in a different clinical trial
- Severe renal impairment (CrCl < 30 ml/min)
- Hepatic disease (Child-Pugh Class C)
- Prisoners
- Pregnant
- Breastfeeding
- Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only in English.)
- Does not have the capacity to consent
- Patients who are known to be allergic to mirabegron or skin patch electrodes
- Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: mirabegron arm
25 mg
|
This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
|
|
Placebo komparator: placebo arm
matching placebo
|
Matchende placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
Patients pushes button when there are symptoms
|
At baseline and again immediately after the completion of drug treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Malmö POTS Symptom Score
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
It is a 12-item questionnaire in which each symptom is rated from 0 to 10 using a visual analogue scale.
The total score range is 0 (no symptom) to 120 (maximal symptom)
|
At baseline and again immediately after the completion of drug treatment
|
|
EQ-5D-5L quality of life score
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
calculated score, best = 1, worst = -0.573
|
At baseline and again immediately after the completion of drug treatment
|
|
Duke Activity Status Index
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
Scores range 0 to 58.2.
The higher the score, the greater the individual's functional capacity.
|
At baseline and again immediately after the completion of drug treatment
|
|
Seattle Angina Questionnaire score
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
Measurement of Angina on a 0-100 scale.
Higher score means better status and fewer symptoms.
|
At baseline and again immediately after the completion of drug treatment
|
|
OAB-q SF
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
Overactive bladder symptom measurements.
best = 0, worst = 100.
|
At baseline and again immediately after the completion of drug treatment
|
|
PROMIS survey
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
PROMIS fatigue score range 30-80.
Higher score = worse fatigue.
|
At baseline and again immediately after the completion of drug treatment
|
|
skin sympathetic nerve activity (SKNA) parameters
Tidsramme: At baseline and again immediately after the completion of drug treatment
|
Average SKNA over 1 - minute windows, measured in μV.
The higher the number, the higher the sympathetic nerve activity.
|
At baseline and again immediately after the completion of drug treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
9. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00004929
- 26BIPA1622610 (Annet stipend/finansieringsnummer: The American Heart Association)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
AHA does not require IPD for studies supported by its grants.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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