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NCT04140721 · ClinicalTrials.gov registry record · Early Phase 1
Autonomic Determinants of POTS - Pilot 2
A Early Phase 1 study of Postural Tachycardia Syndrome, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04140721: Active Early Phase 1 study of Postural Tachycardia Syndrome, sponsored by Vanderbilt University Medical Center.
NCT04140721 is a Early Phase 1 study of Postural Tachycardia Syndrome that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 48 participants, below the 80-participant average among 19 other Postural Tachycardia Syndrome trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04140721, a Early Phase 1 study of Postural Tachycardia Syndrome, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
VOSS is a validated questionnaire that consists of 9 items: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. Each item is scored on a 0 to 10 scale (with 0 reflecting absence of symptoms), and the change of the total scores (range: 0-90) from supine to upright postures (delta VOSS) will be used as a measure of orthostatic symptom burden. The primary outcome measure will be the difference in orthostatic
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Moxonidine Pill
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT04140721 still lists
NCT04140721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 80-participant average among 19 other Postural Tachycardia Syndrome trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Postural Tachycardia Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04140721 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04140721 about?
NCT04140721 is a clinical study titled "Autonomic Determinants of POTS - Pilot 2". 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 norma...
What is the current status of trial NCT04140721?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2021-08-31. Estimated completion is 2025-12-31.
What conditions does trial NCT04140721 study?
This clinical trial studies the following conditions: Postural Tachycardia Syndrome.
What interventions are being tested in trial NCT04140721?
The interventions under investigation include: Placebo oral tablet (DRUG), Moxonidine Pill (DRUG).
Who is sponsoring clinical trial NCT04140721?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04140721 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postural Tachycardia Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04140721's enrollment target sits among peer trials
48 9th of 19 higher than 10 of 19 other Postural Tachycardia Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postural Tachycardia Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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