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Not yet recruiting NCT07585513

Beta-3 Enhanced Autonomic Therapy for POTS

Phase II Interventional Postural Orthostatic Tachycardia Syndrome (POTS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mirabegron, Placebo.
Who it may be relevant to
Registry conditions: Postural Orthostatic Tachycardia Syndrome (POTS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms

Overview

The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.

Detailed description

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.

Interventions

  • Drug Mirabegron
    This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
  • Drug Placebo
    Matching placebo

Primary outcome measures

  • Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor. [Time frame: At baseline and again immediately after the completion of drug treatment]
Secondary outcome measures (7)
  • Malmö POTS Symptom Score [Time frame: At baseline and again immediately after the completion of drug treatment]
  • EQ-5D-5L quality of life score [Time frame: At baseline and again immediately after the completion of drug treatment]
  • Duke Activity Status Index [Time frame: At baseline and again immediately after the completion of drug treatment]
  • Seattle Angina Questionnaire score [Time frame: At baseline and again immediately after the completion of drug treatment]
  • OAB-q SF [Time frame: At baseline and again immediately after the completion of drug treatment]
  • PROMIS survey [Time frame: At baseline and again immediately after the completion of drug treatment]
  • skin sympathetic nerve activity (SKNA) parameters [Time frame: At baseline and again immediately after the completion of drug treatment]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07585513 · STUDY00004929 · 26BIPA1622610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗