Trial · NCT03685149

Pilot Randomized Trial With Flecainide in ARVC Patients

NCT03685149, Phase 2, Completed, University of Rochester; results first posted 2024-08-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pilot Randomized Trial With Flecainide in ARVC Patients. Trials, record NCT03685149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03685149

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pilot Randomized Trial With Flecainide in ARVC Patients
NCT number: NCT03685149
Status: Completed
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: University of Rochester
Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy
Interventions: Flecainide Pill, Placebo
First posted: 2018-09-26
Last updated: 2024-08-20
Results first posted: 2024-08-20

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Ventricular Ectopic Beats (VEBs) Per Day	7-day period	Number of ventricular ectopic beats (VEBs) per day in a 7-day ECG recording
Secondary	Number of Participants With Proarrhythmic Response to Flecainide	4 weeks	Nonsustained and sustained ventricular tachycardia and ventricular fibrillation recorded by implantable cardioverter-defibrillator (ICD) during 4-week treatment periods.
Secondary	Ventricular Tachycardia (VT) Burden	7-day period	Number of VT runs/episodes recorded per day on a 7-day ECG recording
Secondary	Number of Atrial Premature Beats (APBs) Per Day	7-day period	Number of atrial premature beats (APBs) per day in a 7-day ECG recording

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Ventricular Ectopic Beats (VEBs) Per Day	7-day period	18 subjects had ECG recordings on placebo and 18 had on flecainide, with 2 recordings missing, 17 subjects had both recordings	number of VEBs per day	MEDIAN
SECONDARY	Number of Participants With Proarrhythmic Response to Flecainide	4 weeks	19 subjects had data regarding ICD-documented arrhythmias	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Ventricular Tachycardia (VT) Burden	7-day period	18 subjects had ECG recordings on placebo and 18 had on flecainide, with 2 recordings missing, 17 subjects had both recordings	number of VTs per day	MEAN
SECONDARY	Number of Atrial Premature Beats (APBs) Per Day	7-day period	18 subjects had ECG recordings on placebo and 18 had on flecainide, with 2 recordings missing, 17 subjects had both recordings	number of APBs per day	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Ventricular Ectopic Beats (VEBs) Per Day	Placebo	2685	Inter-Quartile Range 1187 to 5431	number of VEBs per day
Number of Ventricular Ectopic Beats (VEBs) Per Day	Flecainide	677	Inter-Quartile Range 310 to 1663	number of VEBs per day
Number of Participants With Proarrhythmic Response to Flecainide	Placebo	3		Participants
Number of Participants With Proarrhythmic Response to Flecainide	Flecainide	3		Participants
Ventricular Tachycardia (VT) Burden	Placebo	0.4	Standard Deviation 0.5	number of VTs per day
Ventricular Tachycardia (VT) Burden	Flecainide	0	Standard Deviation 0.1	number of VTs per day
Number of Atrial Premature Beats (APBs) Per Day	Placebo	32	Inter-Quartile Range 4 to 102	number of APBs per day
Number of Atrial Premature Beats (APBs) Per Day	Flecainide	8	Inter-Quartile Range 1 to 61	number of APBs per day

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (4 Weeks)	STARTED	Placebo, Then Flecainide	11
First Intervention (4 Weeks)	STARTED	Flecainide, Then Placebo	11
First Intervention (4 Weeks)	COMPLETED	Placebo, Then Flecainide	10
First Intervention (4 Weeks)	COMPLETED	Flecainide, Then Placebo	9
First Intervention (4 Weeks)	NOT COMPLETED	Placebo, Then Flecainide	1
First Intervention (4 Weeks)	NOT COMPLETED	Flecainide, Then Placebo	2
Washout (1 Week)	STARTED	Placebo, Then Flecainide	10
Washout (1 Week)	STARTED	Flecainide, Then Placebo	9
Washout (1 Week)	COMPLETED	Placebo, Then Flecainide	10
Washout (1 Week)	COMPLETED	Flecainide, Then Placebo	9

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Chest pain	Cardiac disorders	Placebo	1	22	1
other	Chest pain	Cardiac disorders	Flecainide	0	22	0
other	Dyspnea	Cardiac disorders	Placebo	1	22	1
other	Dyspnea	Cardiac disorders	Flecainide	0	22	0
other	Headache	Nervous system disorders	Placebo	0	22	0
other	Headache	Nervous system disorders	Flecainide	1	22	1
other	Nausea	Gastrointestinal disorders	Placebo	1	22	1
other	Nausea	Gastrointestinal disorders	Flecainide	0	22	0
other	Palpitations	Cardiac disorders	Placebo	2	22	2
other	Palpitations	Cardiac disorders	Flecainide	0	22	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	22
Total, all-cause mortality	Flecainide	0	22
Total, other adverse events	Placebo	7	22
Total, other adverse events	Flecainide	2	22
Total, serious adverse events	Placebo	1	22
Total, serious adverse events	Flecainide	1	22

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19560088	BACKGROUND	PubMed
20172911	BACKGROUND	PubMed
27939893	BACKGROUND	PubMed
28052233	BACKGROUND	PubMed
28740174	BACKGROUND	PubMed
37979797	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R34HL143372	Pilot Randomized Trial with Flecainide in ARVC Patients	ZAREBA, WOJCIECH	UNIVERSITY OF ROCHESTER	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2018 to 2019

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Flecainide vs Placebo: Number of Participants With Proarrhythmic Response to Flecainide	Trial comparisons
Flecainide vs Placebo: deaths from any cause	Trial comparisons
Flecainide vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03685149

GET https://conductscience.org/api/trials/v1/NCT03685149/registered

API reference For AI assistants