Trial Outcomes & Findings for Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia (NCT NCT01117454)

Last Updated: 2017-06-14

Results Overview

Hypothesis: the addition of oral flecainide to standard therapy will reduce ventricular ectopy and/or VT on treadmill exercise treadmill testing in patients with CPVT, compared to placebo plus standard therapy.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

3 months

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Flecainide Then Placebo In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy. flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml	Placebo Then Flecainide In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy. flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
Overall Study STARTED	6	8
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Flecainide Then Placebo In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy. flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml	Placebo Then Flecainide In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy. flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
Overall Study Pregnancy	0	1

Baseline Characteristics

Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flecainide Then Placebo n=6 Participants In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy. flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml	Placebo Then Flecainide n=8 Participants In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy. flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=99 Participants	7 Participants n=107 Participants	10 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Region of Enrollment United States	6 participants n=99 Participants	8 participants n=107 Participants	14 participants n=206 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 1 participant did not complete treadmill test

Outcome measures

Outcome measures
Measure	Flecainide n=12 Participants All participants when receiving flecainide	Placebo n=12 Participants All participants when receving placebo
Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing	2 Participants	9 Participants

Adverse Events

Flecainide

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flecainide n=13 participants at risk All participants when receiving flecainide	Placebo n=13 participants at risk All participants when receving placebo
Psychiatric disorders Suicidal Ideation	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Cardiac disorders Implantable Cardioverter-Defibrillator Infection	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Musculoskeletal and connective tissue disorders Back pain requiring Surgery	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Immune system disorders Allergic Reaction requiring Hospitalization	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Cardiac disorders Supraventricular Tachycardia	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Cardiac disorders Vasovagal Syncope	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months

Other adverse events

Additional Information

Dr. Prince J. Kannankeril, MD, MSCI

Vanderbilt University Medical Center

Phone: 615 322-7447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Flecainide n=13 participants at risk All participants when receiving flecainide	Placebo n=13 participants at risk All participants when receving placebo
Gastrointestinal disorders Diarrhea	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Musculoskeletal and connective tissue disorders Headache	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	15.4% 2/13 • Number of events 3 • Participants were followed for the duration of the study, an average of 26 months
Infections and infestations Sinusitis	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Injury, poisoning and procedural complications Musculoskelatal Injury	23.1% 3/13 • Number of events 3 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Nervous system disorders lightheadedness	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Cardiac disorders palpitations	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	15.4% 2/13 • Number of events 2 • Participants were followed for the duration of the study, an average of 26 months
Nervous system disorders dizziness	15.4% 2/13 • Number of events 2 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Psychiatric disorders phantom shock	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Gastrointestinal disorders anorexia	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
General disorders fatigue	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Eye disorders blurry vision	30.8% 4/13 • Number of events 5 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Gastrointestinal disorders constipation	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Infections and infestations influenza	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
General disorders insominia	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Musculoskeletal and connective tissue disorders left side pain	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months
Cardiac disorders Hypertension	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months
Cardiac disorders Hypotension	0.00% 0/13 • Participants were followed for the duration of the study, an average of 26 months	7.7% 1/13 • Number of events 1 • Participants were followed for the duration of the study, an average of 26 months