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NCT03261570 · ClinicalTrials.gov registry record · Early Phase 1
Cardiovagal Baroreflex Deficits Impair Neurovascular Coupling and Cognition in POTS
A Early Phase 1 study, sponsored by New York Medical College.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 51
- Enrollment target
NCT03261570: Completed Early Phase 1 study, sponsored by New York Medical College.
NCT03261570 is a Early Phase 1 study that has completed, run by New York Medical College. The registered enrollment target is 51 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03261570, a Early Phase 1 study, has completed, sponsored by New York Medical College.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
Postural tachycardia syndrome (POTS), is the chronic form of orthostatic intolerance associated with excessive upright tachycardia, and occurs predominantly in young females (\>85%). Among its most troubling symptoms are lightheadedness, fatigue, and decreased memory often called "brain fog" by patients. Task-related neurovascular coupling (NVC) links neural activity to an increase in CBF known as "functional hyperemia". Although memory task performance and NVC deteriorated with angle of tilt in POTS but not healthy controls, cerebral blood flow (CBF) remained similar to control. Instead, the investigators observed extensive narrow band low frequency (0.07-0.13 Hz) oscillations in BP (OBP) that entrained and amplified oscillations in CBF (OCBF). OBP and OCBF increased with tilt angle and caused impaired working memory and reduced functional hyperemia. The cardiovagal baroreflex couples BP to HR to buffer BP changes. The investigators hypothesize that the cardiovagal baroreflex becomes progressively impaired with orthostasis in POTS, but not in healthy volunteers, and accounts for OBP, OCBF, and loss of NVC; further, improving the baroreflex reduces OBP, OCBF and Brain Fog in POTS.
Primary Outcome
Cardiovagal Baroreflex during orthostatic stress in unmedicated POTS patients compared to unmedicated control subjects during each angle of incremental tilt. The unmedicated baroreflex measurement will be repeated in POTS patients to similar measurements after treatment with placebo, pyridostigmine or digoxin. Baroreflex measurements will be obtained using the standard "modified Oxford" technique.
Interventions
- DRUG Placebo
- DRUG Digoxin
- DRUG Pyridostigmine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2022-06-01 |
| Phase | Early Phase 1 |
What the finished NCT03261570 record still lists
NCT03261570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03261570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03261570 about?
NCT03261570 is a clinical study titled "Cardiovagal Baroreflex Deficits Impair Neurovascular Coupling and Cognition in POTS". Postural tachycardia syndrome (POTS), is the chronic form of orthostatic intolerance associated with excessive upright tachycardia, and occurs predominantly in young females (\>85%). Among its most troubling symptoms are lightheadedness, fatigue, and decreased memory often called "brain fog" by pati...
What is the current status of trial NCT03261570?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 51 participants. The study started on 2017-07-01. Estimated completion is 2022-06-01.
What interventions are being tested in trial NCT03261570?
The interventions under investigation include: Placebo (DRUG), Digoxin (DRUG), Pyridostigmine (DRUG).
Who is sponsoring clinical trial NCT03261570?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03261570's enrollment target sits among peer trials
51 486th of 2000 higher than 1,508 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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