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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 is a Early Phase 1 study that has completed, run by New York Medical College. The registered enrollment target is 51 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Digoxin
  • DRUG Pyridostigmine

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2017-07-01
Est. Completion 2022-06-01
Phase Early Phase 1

Sponsor

New York Medical College

47 total trials

What the Registry Record Tells You About NCT03261570

The ClinicalTrials.gov registry entry for NCT03261570 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York Medical College, which has 47 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03261570 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.