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Blood Pressure Medication

Moxonidine for Postural Orthostatic Tachycardia Syndrome

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
Meets criteria for postural tachycardia syndrome (POTS)
POTS with primary central sympathetic activation (psPOTS) as defined as having resting MSNA ≥ 25 bursts/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 30 min supine to after 15 min of 60 degrees upright tilt (delta hr), 2-3 hours after a dose of the treatment assigned for the previous period.
Awards & highlights

Study Summary

This trial will help determine if a blood pressure medication can improve symptoms in people with POTS, a condition characterized by a high heart rate and disabling symptoms during standing.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Moxonidine may cause side effects such as dry mouth, fatigue, headache, dizziness upon standing (due to lowered blood pressure), sleep disturbances and skin reactions. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with postural tachycardia syndrome (POTS).
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I have been diagnosed with a specific type of POTS with high nerve activity.
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I have had symptoms when standing for 6 months without any other sudden illness causing it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 30 min supine to after 15 min of 60 degrees upright tilt (delta voss), 2-3 hours after a dose of the treatment assigned for the previous period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 30 min supine to after 15 min of 60 degrees upright tilt (delta voss), 2-3 hours after a dose of the treatment assigned for the previous period. for reporting.

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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral tablet
2019
Completed Phase 4
~2450

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,579 Total Patients Enrolled
10 Trials studying Postural Orthostatic Tachycardia Syndrome
442 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,149 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
861 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

Moxonidine (Blood Pressure Medication) Clinical Trial Eligibility Overview. Trial Name: NCT04140721 — Phase < 1
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Placebo then Moxonidine, Moxonidine then Placebo
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Moxonidine Highlights & Side Effects. Trial Name: NCT04140721 — Phase < 1
Moxonidine (Blood Pressure Medication) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04140721 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity for enrolment of this experiment?

"Affirmative. Information available on clinicaltrials.gov highlights that this medical experiment, which was initially published on August 31st 2021, is currently enrolling volunteers. Approximately 48 participants are required to be sourced from one health facility."

Answered by AI

Is recruitment for this endeavor currently taking place?

"Reportedly, this medical trial is actively enrolling participants. Clinicialtrials.gov documents the inception of the study on August 31st 2021 and attests to its most recent update occurring on July 21st 2022."

Answered by AI

What other investigations have taken place involving Moxonidine Pill?

"At present, 5 trials for Moxonidine Pill are ongoing. None of these studies have advanced to Phase 3 yet; the majority occurring in Nashville, Tennessee with an additional 5 locations conducting their own independent research."

Answered by AI

Are persons aged sixty and over eligible for participation in this trial?

"This medical trial is enrolling individuals aged 18 to 55."

Answered by AI

Who qualifies for this research project?

"This research project is looking for 48 volunteers aged between 18 and 55 who have tachycardia. In addition, they must present with psPOTS (primary central sympathetic activation as indicated by MSNA ≥ 25 bursts/min) and POTS (heart rate increase of at least 30 beats per minute within 10 minutes of upright posture). They cannot display orthostatic hypotension or any other acute cause; furthermore, the participants need to be in the follicular phase of their menstrual cycle and give informed consent willingly."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

How long does it take to get screened and hear more about the study?
PatientReceived no prior treatments

Why did patients apply to this trial?

I’ve been suffering with POTS for a few years but now have confirmed diagnosis by Tilt Table. Tried 2 drugs with not much benefit to the quality of life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Autonomic Determinants of POTS - Pilot 2
Andre' Diedrich 2021. "Autonomic Determinants of POTS - Pilot 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04140721.
~10 spots leftby Jan 2025
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