48 Participants Needed

Moxonidine for Postural Orthostatic Tachycardia Syndrome

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VU
TC
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Overseen ByAndre Diedrich, MD, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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

AD

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

Able and willing to provide informed consent
I have been diagnosed with postural tachycardia syndrome (POTS).
You are in the first half of your menstrual cycle.
See 5 more

Exclusion Criteria

I cannot stop taking my medication that affects my blood pressure or heart function.
You have a body mass index (BMI) higher than 30.
I have a condition like heart disease, high blood pressure, or diabetes, or I'm currently taking certain medications like steroids.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Evaluation

Baseline evaluations are conducted before starting the treatment phase

1 week
1 visit (in-person)

Treatment

Participants receive either placebo or moxonidine for 2 weeks, followed by crossover to the other treatment for another 2 weeks

4 weeks
2 visits (in-person) for study testing after each 2-week period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Moxonidine
  • Placebo oral tablet
Trial Overview The study tests Moxonidine's effect on POTS symptoms compared to a placebo. Moxonidine is a blood pressure medication that reduces sympathetic nerve activity which might help lower heart rate and improve standing tolerance in patients with high resting sympathetic activity.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Placebo then MoxonidineExperimental Treatment2 Interventions
After screening/baseline evaluations, patients will be discharged home on placebo identical to moxonidine once daily PO. After two weeks, the patients will be re-admitted for study testing while on placebo. At completion of this testing, patients will start taking moxonidine 0.2-0.4 mg/day PO to be continued at home. After two weeks, the patients will be re-admitted for study testing while on moxonidine.
Group II: Moxonidine then PlaceboExperimental Treatment2 Interventions
After screening/baseline evaluations, patients will be discharged home on moxonidine 0.2-0.4 mg/day PO. After two weeks, the patients will be re-admitted for study testing while on moxonidine. At completion of this testing, patients will start taking matching placebo once daily PO to be continued at home. After two, the patients will be re-admitted for study testing while on placebo.

Moxonidine is already approved in European Union, Canada, China, Switzerland, United Kingdom for the following indications:

🇪🇺
Approved in European Union as Physiotens for:
  • Hypertension
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Approved in Canada as Physiotens for:
  • Hypertension
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Approved in China as Moxonidine for:
  • Hypertension
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Approved in Switzerland as Physiotens for:
  • Hypertension
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Approved in United Kingdom as Physiotens for:
  • Hypertension

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

In a case series of six patients with postural orthostatic tachycardia syndrome (POTS) treated with low-dose naltrexone (LDN), three patients reported improvement in their symptoms, while two discontinued treatment due to lack of perceived benefit.
LDN demonstrated a favorable safety profile with no reported side effects, but the overall efficacy remains unclear, as patient-reported outcomes showed inconsistent changes, highlighting the need for larger, high-quality randomized controlled trials.
Low-Dose Naltrexone Use in Postural Orthostatic Tachycardia Syndrome: A Case Series.Stallkamp Tidd, SJ., Cantrell, C., Greene, BD., et al.[2023]
In a study of 708 patients with postural orthostatic tachycardia syndrome, various medications were found to effectively manage symptoms, with success rates of 52.2% for light-headedness and 53.4% for pain.
The study highlighted that while insomnia treatment was more effective in females, other symptom therapies showed no gender differences, indicating that medications can be tailored to individual symptoms for better management.
Utilisation of medications to reduce symptoms in children with postural orthostatic tachycardia syndrome.Boris, JR., Bernadzikowski, T.[2019]
In a meta-analysis of 6 studies involving 783 patients with neurogenic orthostatic hypotension, both droxidopa and midodrine significantly increased standing systolic blood pressure (sSBP) compared to placebo, with midodrine showing a greater increase (17 mm Hg) than droxidopa (6.2 mm Hg).
While both medications improved sSBP, midodrine was associated with a significantly higher risk of supine hypertension compared to placebo, indicating that droxidopa may be a safer option for patients concerned about this side effect.
Standing and Supine Blood Pressure Outcomes Associated With Droxidopa and Midodrine in Patients With Neurogenic Orthostatic Hypotension: A Bayesian Meta-analysis and Mixed Treatment Comparison of Randomized Trials.Chen, JJ., Han, Y., Tang, J., et al.[2019]

References

Low-Dose Naltrexone Use in Postural Orthostatic Tachycardia Syndrome: A Case Series. [2023]
Utilisation of medications to reduce symptoms in children with postural orthostatic tachycardia syndrome. [2019]
Standing and Supine Blood Pressure Outcomes Associated With Droxidopa and Midodrine in Patients With Neurogenic Orthostatic Hypotension: A Bayesian Meta-analysis and Mixed Treatment Comparison of Randomized Trials. [2019]
Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. [2021]
Postural Orthostatic Tachycardia Syndrome Misdiagnosed as Anxiety: A Case Report with a Review of Therapy and Pathophysiology. [2020]
I1-imidazoline agonist moxonidine decreases sympathetic nerve activity and blood pressure in hypertensives. [2019]
Safety and tolerability of moxonidine in the treatment of hypertension. [2018]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Effect of moxonidine on the cardiac chronotropic regulation in hypertensive rats SHR-SP]. [2014]
Moxonidine in the treatment of overweight and obese patients with the metabolic syndrome: a postmarketing surveillance study. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Hemodynamic and neurohumoral effects of moxonidine in patients with essential hypertension. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Pharmacology of moxonidine, an I1-imidazoline receptor agonist. [2019]
General pharmacology of the novel centrally acting antihypertensive agent moxonidine. [2014]
Moxonidine: a review of its use in essential hypertension. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Acute hemodynamic and neurohumoral effects of moxonidine in congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. [2019]
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