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Blood Pressure Medication
Moxonidine for Postural Orthostatic Tachycardia Syndrome (POTS)
Phase < 1
Recruiting
Led By André Diedrich, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female/male subjects, age 18-55 years
POTS with primary central sympathetic activation (psPOTS) as defined as having resting muscle sympathetic nerve activity (MSNA) greater than or equal to 25 bursts/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 30 min supine to after 15 min upright (delta voss), 2-3 hours after placebo or moxonidine intake [delta (delta voss)].
Awards & highlights
Study Summary
This trial is studying whether a blood pressure medication can help improve symptoms in people with postural tachycardia syndrome, which mostly affects young women and causes significant disability.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Moxonidine may cause side effects such as dry mouth, drowsiness, headache, fatigue, skin reactions or gastrointestinal issues. As it lowers blood pressure and heart rate, some individuals might experience dizziness or fainting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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I have been diagnosed with a specific type of POTS based on nerve activity tests.
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I am between 18 and 55 years old.
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My heart rate increases significantly when I stand up, without a drop in blood pressure, and I've felt this way for over 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 30 min supine to after 15 min upright (delta hr), 2-3 hours after placebo or moxonidine intake [delta (delta hr)].
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 30 min supine to after 15 min upright (delta hr), 2-3 hours after placebo or moxonidine intake [delta (delta hr)].
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Orthostatic Symptom Burden [delta (delta VOSS)]
Secondary outcome measures
Change in Orthostatic Change in Heart Rate [delta (delta HR)]
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MoxonidineExperimental Treatment1 Intervention
Patients will receive a single oral dose of moxonidine 0.4 mg.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive a single oral dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moxonidine
2011
Completed Phase 4
~480
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,144 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
861 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,448 Total Patients Enrolled
10 Trials studying Postural Orthostatic Tachycardia Syndrome
442 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
André Diedrich, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
48 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had symptoms when standing for 6 months without any other sudden illness causing it.You have a body mass index (BMI) over 30.You are in the first half of your menstrual cycle, between days 5 and 13 of a 28-day cycle.I am between 18 and 55 years old.I have been diagnosed with a specific type of POTS based on nerve activity tests.I am between 18 and 55 years old.Your heart rate increases by 30 or more beats per minute when you stand up.I have a condition like diabetes that affects my nerves.I have hardening of the neck arteries or have had neck surgery.My heart rate increases significantly when I stand up, without a drop in blood pressure, and I've felt this way for over 6 months.I cannot stop taking my medication that affects my blood pressure or heart function.My physical fitness level is lower than expected for my age and sex.You are someone who smokes.
Research Study Groups:
This trial has the following groups:- Group 1: Moxonidine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals able to join this research endeavor currently?
"Affirmative, the data on clinicaltrials.gov attests to this trial's active recruitment status. Initially posted August 27th 2019 and most recently edited January 19th 2022, it is now seeking 48 patients from a single medical centre."
Answered by AI
What are the qualifications for participating in this clinical trial?
"This research trial seeks 48 participants, both male and female between the ages of 18-55, who have a history of marijuana abuse. Moreover, subjects must demonstrate an increase in heart rate by 30 beats per minute within 10 minutes after assuming an upright position as well as chronic symptoms associated with this posture for at least 6 months without any other acute cause present."
Answered by AI
Does this clinical trial allow patients aged 70 or above to participate?
"As stated in the trial requirements, only individuals between 18 and 55 years of age are eligible for participation."
Answered by AI
How many participants have enrolled in this scientific exploration?
"Affirmative. According to clinicaltrials.gov, this research is presently enrolling participants; the trial was first published in August of 2019 and was last updated on January 19th 2022. This medical study requires 48 people from a single site for inclusion."
Answered by AI
Could you please provide an overview of research that has been conducted with Moxonidine?
"Currently, there are 5 ongoing clinical trials exploring the effects of Moxonidine with none in Phase 3. Nashville, Tennessee remains the epicenter for these investigations; however, other cities across America have also contributed to their advancement."
Answered by AI
Who else is applying?
What state do they live in?
Hawaii
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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