A Phase 2 interventional study of Flecainide Pill and Placebo in Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by University of Rochester. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by University of Rochester · Phase 2, Interventional, and Treatment
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).
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).
Secondary specific aims are:
to assess safety of flecainide administration with particular emphasis on proarrhythmic response measured by:
Study population will include 38 ARVC patients diagnosed with the 2010 ARVC Task Force Criteria who are at least 18 years old, have implanted ICD, and show at least 500 VEBs in a 24-hour Holter recording. Patients on other pharmacological antiarrhythmic treatment other than beta-blockers and patients with prior catheter VT ablation will be excluded.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 22 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The same subjects will be treated in a random order with flecainide or placebo for 4 weeks each with 1 week washout between crossover periods.
Drug: Flecainide Pill · Drug: Placebo
The same subjects will be treated in a random order with flecainide or placebo for 4 weeks each with 1 week washout between crossover periods.
Drug: Flecainide Pill · Drug: Placebo
Flecainide pill or placebo 100 mg administered twice a day for 4 weeks each
Also known as: Tambocor
Flecainide pill or placebo 100 mg administered twice a day for 4 weeks each
Number of Ventricular Ectopic Beats (VEBs) Per Day
Number of ventricular ectopic beats (VEBs) per day in a 7-day ECG recording
Time frame: 7-day period
Number of Participants With Proarrhythmic Response to Flecainide
Nonsustained and sustained ventricular tachycardia and ventricular fibrillation recorded by implantable cardioverter-defibrillator (ICD) during 4-week treatment periods.
Time frame: 4 weeks
Ventricular Tachycardia (VT) Burden
Number of VT runs/episodes recorded per day on a 7-day ECG recording
Time frame: 7-day period
Number of Atrial Premature Beats (APBs) Per Day
Number of atrial premature beats (APBs) per day in a 7-day ECG recording
Time frame: 7-day period
There were 7 enrolling sites in the study. Recruitment took place at 6 enrolling sites between July 23, 2019 and May 2, 2022.
| Milestone | Placebo, Then Flecainide | Flecainide, Then Placebo |
|---|---|---|
| Started | 11 | 11 |
| Completed | 10 | 9 |
| Not completed | 1 | 2 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Placebo, Then Flecainide | Flecainide, Then Placebo |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
| Milestone | Placebo, Then Flecainide | Flecainide, Then Placebo |
|---|---|---|
| Started | 10 | 9 |
| Completed | 9 | 9 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
Number of ventricular ectopic beats (VEBs) per day in a 7-day ECG recording
| number of VEBs per day | Placebo | Flecainide |
|---|---|---|
| Number of Ventricular Ectopic Beats (VEBs) Per Day | 2685 (1187 to 5431) | 677 (310 to 1663) |
Nonsustained and sustained ventricular tachycardia and ventricular fibrillation recorded by implantable cardioverter-defibrillator (ICD) during 4-week treatment periods.
| Participants | Placebo | Flecainide |
|---|---|---|
| Number of Participants With Proarrhythmic Response to Flecainide | 3 | 3 |
Number of VT runs/episodes recorded per day on a 7-day ECG recording
| number of VTs per day | Placebo | Flecainide |
|---|---|---|
| Ventricular Tachycardia (VT) Burden | 0.4 ± 0.5 | 0 ± 0.1 |
Number of atrial premature beats (APBs) per day in a 7-day ECG recording
| number of APBs per day | Placebo | Flecainide |
|---|---|---|
| Number of Atrial Premature Beats (APBs) Per Day | 32 (4 to 102) | 8 (1 to 61) |
Collected over 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/22 (0%) | 1/22 (4.5%) | 7/22 (31.8%) |
| Flecainide | 0/22 (0%) | 1/22 (4.5%) | 2/22 (9.1%) |
| Event | Placebo | Flecainide |
|---|---|---|
| Ventricular tachycardia requiring implantabale cardioverter defibrillator (ICD) therapyCardiac disorders | 1/22 | 1/22 |
| Event | Placebo | Flecainide |
|---|---|---|
| PalpitationsCardiac disorders | 2/22 | 0/22 |
| Chest painCardiac disorders | 1/22 | 0/22 |
| DyspneaCardiac disorders | 1/22 | 0/22 |
| HeadacheNervous system disorders | 0/22 | 1/22 |
| NauseaGastrointestinal disorders | 1/22 | 0/22 |
| SyncopeCardiac disorders | 0/22 | 1/22 |
| ParesthesiaNervous system disorders | 1/22 | 0/22 |
| Hot flashesGeneral disorders | 1/22 | 0/22 |
| Age, Categorical(Participants) | Placebo, Then Flecainide | Flecainide, Then Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 22 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Placebo, Then Flecainide | Flecainide, Then Placebo | Total |
|---|---|---|---|
| Mean | 47 ± 13 | 43 ± 14 | 45 ± 13 |
| Sex: Female, Male(Participants) | Placebo, Then Flecainide | Flecainide, Then Placebo | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 5 | 5 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Placebo, Then Flecainide | Flecainide, Then Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 11 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo, Then Flecainide | Flecainide, Then Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 11 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo, Then Flecainide | Flecainide, Then Placebo | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — This is a small pilot trial with limited dataset which will be mostly explored by enrolling center investigators.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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