Moxonidine for Postural Orthostatic Tachycardia Syndrome (POTS)

Overseen By Andre Diedrich, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: Corticosteroids, NSAIDs, Statins, others

Disqualifiers: Pregnancy, Smoking, Diabetes, Hypertension, others

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Single dose administration

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications that affect autonomic function, blood pressure, or blood volume. If you are on such medications, you will need to withdraw from them to participate.

Is moxonidine safe for human use?

Moxonidine has been studied for its safety in treating high blood pressure, with common side effects including dry mouth, sleepiness, headache, and dizziness. Serious side effects are rare, and it does not worsen conditions like diabetes or interact negatively with certain medications. Overall, it has a good safety profile for managing mild-to-moderate hypertension. ^{1 2 3 4 5}

How is the drug Moxonidine unique in treating POTS?

Moxonidine is unique for POTS as it primarily targets the sympathetic nervous system, potentially reducing the excessive heart rate increase seen in POTS by acting on specific receptors in the brain, which is different from other treatments that focus on blood pressure or volume expansion. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests Moxonidine, a medication that calms overactive nerves controlling blood pressure and heart rate, on patients with POTS who have high nerve activity. The goal is to see if it can lower heart rate and improve symptoms when standing. Moxonidine is designed to reduce blood pressure with fewer side effects compared to older medications.

Research Team

André Diedrich, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for men and women aged 18-55 with Postural Orthostatic Tachycardia Syndrome (POTS) characterized by a rapid heartbeat upon standing. Participants must have high resting sympathetic nerve activity, not be pregnant or severely overweight, and cannot be taking certain medications that affect autonomic function.

Inclusion Criteria

I have had symptoms when standing for 6 months without any other sudden illness causing it.

You are in the first half of your menstrual cycle, between days 5 and 13 of a 28-day cycle.

I have been diagnosed with a specific type of POTS based on nerve activity tests.

Exclusion Criteria

I am not currently taking oral corticosteroids, have no infections, and am not using NSAIDs.

I have a condition like heart disease, high blood pressure, I smoke, have high cholesterol, arthritis, or diabetes.

You have a body mass index (BMI) over 30.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of moxonidine or placebo to assess the effects on orthostatic symptoms and hemodynamics

Single dose administration

1 visit (in-person)

Observation

Participants are monitored for changes in heart rate and orthostatic symptom burden after administration

2-3 hours

Continuous monitoring during visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Moxonidine
• Placebo

Trial Overview The study tests the effect of Moxonidine, a blood pressure medication that reduces sympathetic nerve activity, on POTS symptoms compared to a placebo. The goal is to see if it can lower heart rate and improve symptoms when standing in patients with high sympathetic activity.

Participant Groups

Group I: Moxonidine Experimental Treatment 1 Intervention

Patients will receive a single oral dose of moxonidine 0.4 mg.

Group II: Placebo Placebo Group 1 Intervention

Patients will receive a single oral dose of 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

Approved in Canada as Physiotens for:

• Hypertension

Approved in China as Moxonidine for:

• Hypertension

Approved in Switzerland as Physiotens for:

• Hypertension

Approved in United Kingdom as Physiotens for:

• Hypertension

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 study of 32 patients with congestive heart failure, a single dose of moxonidine significantly reduced elevated plasma norepinephrine levels and produced a dose-dependent vasodilator response, leading to lower systemic and pulmonary arterial pressures.

Moxonidine was well tolerated and demonstrated substantial hemodynamic improvements, suggesting that further trials are warranted to assess its long-term efficacy in combination with standard CHF treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute hemodynamic and neurohumoral effects of moxonidine in congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Dickstein, K., Manhenke, C., Aarsland, T., et al.[2019]

Moxonidine, administered for two weeks at doses of 2 or 10 mg/kg, significantly reduced cardiac sympathetic tone in stroke-prone spontaneously hypertensive rats by 24.3% and 32.2%, respectively.

The treatment also improved cardiac baroreflex function, increasing the baroreflex gain in a dose-dependent manner, which suggests that moxonidine effectively modulates heart rate control mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of moxonidine on the cardiac chronotropic regulation in hypertensive rats SHR-SP]. Khokhlova, ON., Murashov, AN., Lavrova, LN., et al.[2014]

In a study involving 4005 patients with hypertension, moxonidine significantly lowered blood pressure from an average of 168/97 mmHg to 141/83 mmHg over 8 weeks, with a response rate of 94% for all patients.

Moxonidine also contributed to a mean weight loss of 1.4 kg, particularly benefiting obese patients, while effectively managing blood pressure in those with metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moxonidine in the treatment of overweight and obese patients with the metabolic syndrome: a postmarketing surveillance study. Sharma, AM., Wagner, T., Marsalek, P.[2017]

Moxonidine, a new antihypertensive agent, has a favorable safety profile with low rates of adverse effects, primarily dry mouth (8-9%) and somnolence (5-8%), over an extensive review of 74 clinical trials involving approximately 370,000 patient-years.

It effectively lowers blood pressure without exacerbating conditions like diabetes or chronic obstructive pulmonary disease, and its adverse effects tend to decrease with longer use, indicating it may be a valuable option for managing mild-to-moderate hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of moxonidine in the treatment of hypertension. Schachter, M., Luszick, J., Jäger, B., et al.[2018]

Moxonidine, an I1-imidazoline receptor agonist, effectively reduces blood pressure in both healthy volunteers and untreated hypertensives by decreasing muscle sympathetic nerve activity, indicating its potential as a treatment for hypertension.

In a study involving 25 hypertensive participants, moxonidine significantly lowered both systolic and diastolic blood pressure without affecting cholesterol levels, suggesting it may also be beneficial for other cardiovascular conditions associated with increased sympathetic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I1-imidazoline agonist moxonidine decreases sympathetic nerve activity and blood pressure in hypertensives. Wenzel, RR., Spieker, L., Qui, S., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute hemodynamic and neurohumoral effects of moxonidine in congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. [2019]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of moxonidine on the cardiac chronotropic regulation in hypertensive rats SHR-SP]. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Moxonidine in the treatment of overweight and obese patients with the metabolic syndrome: a postmarketing surveillance study. [2017]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and tolerability of moxonidine in the treatment of hypertension. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

I1-imidazoline agonist moxonidine decreases sympathetic nerve activity and blood pressure in hypertensives. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Orthostatic and non-orthostatic headache in postural tachycardia syndrome. [2011]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Postural orthostatic tachycardia syndrome]. [2017]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Postural orthostatic tachycardia syndrome]. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Droxidopa in the Treatment of Postural Orthostatic Tachycardia Syndrome. [2017]

10. Croatia pubmed.ncbi.nlm.nih.gov

The incidence of postural orthostatic tachycardia syndrome in the population of Zagreb, Croatia. [2021]