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NCT03182725 · ClinicalTrials.gov registry record · Phase 3
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
A Phase 3 study of Postural Orthostatic Tachycardia Syndrome, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 3
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT03182725 is a Phase 3 study of Postural Orthostatic Tachycardia Syndrome that has completed, run by University of California, San Diego. The registered enrollment target is 37 participants, below the 9,241-participant average among 11 other Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03182725, a Phase 3 study of Postural Orthostatic Tachycardia Syndrome, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120 beats/min within the first ten minutes of a diagnostic tilt table test without postural hypotension. There are currently no effective treatment methods for POTS. However, several studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has been also used for treatment of inappropriate sinus tachycardia with good benefit. The hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve functional status in patients with POTS.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ivabradine
Study Locations (1)
California
- University of California, San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2020-05-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03182725
The ClinicalTrials.gov registry entry for NCT03182725 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,241-participant average among 11 other Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (100% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postural Orthostatic Tachycardia Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03182725 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03182725 about?
NCT03182725 is a clinical study titled "Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome". Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined ...
What is the current status of trial NCT03182725?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2018-02-06. Estimated completion is 2020-05-08.
What conditions does trial NCT03182725 study?
This clinical trial studies the following conditions: Postural Orthostatic Tachycardia Syndrome.
What interventions are being tested in trial NCT03182725?
The interventions under investigation include: Placebo (DRUG), Ivabradine (DRUG).
Who is sponsoring clinical trial NCT03182725?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03182725 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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