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NCT03685149 · ClinicalTrials.gov registry record · Phase 2
Pilot Randomized Trial With Flecainide in ARVC Patients
A Phase 2 study of Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 6
- Study locations
NCT03685149 is a Phase 2 study of Arrhythmogenic Right Ventricular Cardiomyopathy that has completed, run by University of Rochester. The registered enrollment target is 22 participants, below the 379-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT03685149, a Phase 2 study of Arrhythmogenic Right Ventricular Cardiomyopathy, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 6
- Study locations
Study Summary
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice. Antiarrhythmic therapy with different agents including beta-blockers, sotalol and amiodarone are usually not effective in reducing risk of arrhythmic events. Recent data indicated that flecainide effectively prevented the arrhythmias observed in the experimental ARVC animals and in small series of ARVC patients. These observations provide a strong rationale for conducting a pilot randomized clinical trial to determine whether flecainide will reduce ventricular arrhythmias in high-risk ARVC patients. This pilot study is designed as randomized double-blinded placebo-controlled crossover trial with administration of 100 mg of Flecainide or matching placebo twice a day for 4 weeks each with a washout period. Primary specific aim of this pilot trial is to determine whether Flecainide administration is associated with a significant reduction of number of ventricular ectopic beats (VEBs) in ARVC patients with implantable cardioverter-defibrillator (ICD).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Flecainide Pill
Study Locations (6)
New York
- New York University - New York
- University of Rochester Medical Center - Rochester
Colorado
- University of Colorado - Denver
Maryland
- John Hopkins University - Baltimore
North Carolina
- Duke University - Durham
Pennsylvania
- University of Pensylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2022-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03685149
The ClinicalTrials.gov registry entry for NCT03685149 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (94% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Arrhythmogenic Right Ventricular Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03685149 reports 6 study locations spanning 5 distinct geographic areas - top geographies include New York, Colorado, Maryland.
Frequently Asked Questions
What is clinical trial NCT03685149 about?
NCT03685149 is a clinical study titled "Pilot Randomized Trial With Flecainide in ARVC Patients". Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice. Antiarrhythmic therapy with different agents including beta-blockers, sotalol...
What is the current status of trial NCT03685149?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2019-07-23. Estimated completion is 2022-07-31.
What conditions does trial NCT03685149 study?
This clinical trial studies the following conditions: Arrhythmogenic Right Ventricular Cardiomyopathy.
What interventions are being tested in trial NCT03685149?
The interventions under investigation include: Placebo (DRUG), Flecainide Pill (DRUG).
Who is sponsoring clinical trial NCT03685149?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03685149 being conducted?
This trial has 6 study locations across Colorado, Maryland, New York, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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