Moxonidine for Postural Orthostatic Tachycardia Syndrome
Trial Summary
Do I have to stop taking my current medications for this trial?
Yes, you must stop taking medications that affect autonomic function, blood pressure, or blood volume to participate in this trial.
Will I have to stop taking my current medications?
Yes, you will need to stop taking medications that affect autonomic function, blood pressure, or blood volume to participate in this trial.
What data supports the idea that Moxonidine for Postural Orthostatic Tachycardia Syndrome is an effective drug?
The available research does not provide any data on the effectiveness of Moxonidine for Postural Orthostatic Tachycardia Syndrome. The studies mentioned focus on other treatments like low-dose naltrexone and propranolol, but not Moxonidine. Therefore, there is no evidence from the provided information to support the idea that Moxonidine is an effective treatment for this condition.12345
What safety data is available for moxonidine?
Moxonidine has been evaluated for safety and tolerability over an 8-year period in 74 clinical trials with an estimated 370,000 patient-years of exposure. Common adverse effects include dry mouth, somnolence, headache, and dizziness, with serious adverse events being rare. The incidence of adverse effects decreases with prolonged use. Moxonidine does not exacerbate conditions like diabetes or COPD and does not interact significantly with medications like hydrochlorothiazide, digoxin, and glibenclamide. Post-marketing surveillance identified additional adverse effects such as nausea and allergic skin reactions.678910
Is moxonidine safe for human use?
Moxonidine has been studied for safety in humans, primarily for treating high blood pressure. Common side effects include dry mouth, sleepiness, headache, and dizziness, but serious side effects are rare. It has been used safely in many patients over several years, and its side effects tend to decrease with continued use.678910
Is the drug Moxonidine a promising treatment for Postural Orthostatic Tachycardia Syndrome?
Moxonidine is a promising drug because it effectively lowers blood pressure and heart rate by reducing the activity of the sympathetic nervous system. It also improves metabolic health, is well tolerated, and can be taken once daily. These benefits suggest it could be helpful for conditions like Postural Orthostatic Tachycardia Syndrome, which involves issues with heart rate and blood pressure.611121314
How does the drug moxonidine differ from other treatments for Postural Orthostatic Tachycardia Syndrome?
Moxonidine is unique because it works by activating specific receptors in the brain called I1-imidazoline receptors, which helps reduce the activity of the sympathetic nervous system, leading to lower blood pressure and heart rate. This central action is different from many other treatments that may not target these specific receptors or have the same effect on sympathetic nerve activity.611121314
What is the purpose of this trial?
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. These patients have high heart rate and disabling symptoms during standing. Quality of life may be poor. The sympathetic nerves in the autonomic nervous system help to maintain normal blood pressures and heart rates during activities of daily life.The purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment.
Research Team
André Diedrich, MD, PhD
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for young women with POTS, a condition causing rapid heartbeat when standing. Participants must have had symptoms for at least 6 months, experience a heart rate increase of ≥30 bpm within 10 minutes of standing without significant blood pressure drops, and be in the early phase of their menstrual cycle. They should not be overweight or suffering from conditions like heart disease, high blood pressure, diabetes, or taking certain medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Evaluation
Baseline evaluations are conducted before starting the treatment phase
Treatment
Participants receive either placebo or moxonidine for 2 weeks, followed by crossover to the other treatment for another 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Moxonidine
- Placebo oral tablet
Moxonidine is already approved in European Union, Canada, China, Switzerland, United Kingdom for the following indications:
- Hypertension
- Hypertension
- Hypertension
- Hypertension
- Hypertension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator