Trial Outcomes & Findings for Pilot Randomized Trial With Flecainide in ARVC Patients (NCT NCT03685149)
NCT ID: NCT03685149
Last Updated: 2024-08-20
Results Overview
Number of ventricular ectopic beats (VEBs) per day in a 7-day ECG recording
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
7-day period
Results posted on
2024-08-20
Participant Flow
There were 7 enrolling sites in the study. Recruitment took place at 6 enrolling sites between July 23, 2019 and May 2, 2022.
Participant milestones
| Measure |
Placebo, Then Flecainide
Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
|
Flecainide, Then Placebo
Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
11
|
11
|
|
First Intervention (4 Weeks)
COMPLETED
|
10
|
9
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
1
|
2
|
|
Washout (1 Week)
STARTED
|
10
|
9
|
|
Washout (1 Week)
COMPLETED
|
10
|
9
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
10
|
9
|
|
Second Intervention (4 Weeks)
COMPLETED
|
9
|
9
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo, Then Flecainide
Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
|
Flecainide, Then Placebo
Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
First Intervention (4 Weeks)
Adverse Event
|
0
|
2
|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention (4 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Pilot Randomized Trial With Flecainide in ARVC Patients
Baseline characteristics by cohort
| Measure |
Placebo, Then Flecainide
n=11 Participants
Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
|
Flecainide, Then Placebo
n=11 Participants
Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 13 • n=5 Participants
|
43 years
STANDARD_DEVIATION 14 • n=7 Participants
|
45 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-day periodPopulation: 18 subjects had ECG recordings on placebo and 18 had on flecainide, with 2 recordings missing, 17 subjects had both recordings
Number of ventricular ectopic beats (VEBs) per day in a 7-day ECG recording
Outcome measures
| Measure |
Placebo
n=18 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Flecainide
n=18 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
Number of Ventricular Ectopic Beats (VEBs) Per Day
|
2685 number of VEBs per day
Interval 1187.0 to 5431.0
|
677 number of VEBs per day
Interval 310.0 to 1663.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 19 subjects had data regarding ICD-documented arrhythmias
Nonsustained and sustained ventricular tachycardia and ventricular fibrillation recorded by implantable cardioverter-defibrillator (ICD) during 4-week treatment periods.
Outcome measures
| Measure |
Placebo
n=19 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Flecainide
n=19 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
Number of Participants With Proarrhythmic Response to Flecainide
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 7-day periodPopulation: 18 subjects had ECG recordings on placebo and 18 had on flecainide, with 2 recordings missing, 17 subjects had both recordings
Number of VT runs/episodes recorded per day on a 7-day ECG recording
Outcome measures
| Measure |
Placebo
n=18 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Flecainide
n=18 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
Ventricular Tachycardia (VT) Burden
|
0.4 number of VTs per day
Standard Deviation 0.5
|
0 number of VTs per day
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 7-day periodPopulation: 18 subjects had ECG recordings on placebo and 18 had on flecainide, with 2 recordings missing, 17 subjects had both recordings
Number of atrial premature beats (APBs) per day in a 7-day ECG recording
Outcome measures
| Measure |
Placebo
n=18 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Flecainide
n=18 Participants
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
Number of Atrial Premature Beats (APBs) Per Day
|
32 number of APBs per day
Interval 4.0 to 102.0
|
8 number of APBs per day
Interval 1.0 to 61.0
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Flecainide
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Flecainide
n=22 participants at risk
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia requiring implantabale cardioverter defibrillator (ICD) therapy
|
4.5%
1/22 • Number of events 2 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
4.5%
1/22 • Number of events 2 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
Flecainide
n=22 participants at risk
Per randomization: 1) Participants first received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Flecainide pill (100 mg) twice a day for 4 weeks with subsequent 1 week of washout.
or 2) Participants first received Flecainide pill (100 mg) twice a day for 4 weeks. After a washout period of 1 week, they then received Placebo pill (matching Flecainide 100 mg) twice a day for 4 weeks, with subsequent 1 week of washout.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
Cardiac disorders
Dyspnea
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
Nervous system disorders
Headache
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
Cardiac disorders
Palpitations
|
9.1%
2/22 • Number of events 2 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
Cardiac disorders
Syncope
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
Nervous system disorders
Paresthesia
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
|
General disorders
Hot flashes
|
4.5%
1/22 • Number of events 1 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
0.00%
0/22 • 4 weeks on Flecainide and 4 weeks on matching Placebo in this cross-over study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place