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Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01117454
First Posted: May 5, 2010
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prince Joseph Kannankeril, Vanderbilt University Medical Center
Results First Submitted: February 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Catecholaminergic Polymorphic Ventricular Tachycardia
Interventions: Drug: Flecainide Acetate
Drug: Placebo
Drug: Beta blocker

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Flecainide Then Placebo   Placebo Then Flecainide
STARTED   6   8 
COMPLETED   6   7 
NOT COMPLETED   0   1 
Pregnancy                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Flecainide Then Placebo   Placebo Then Flecainide   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   8   14 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      3  50.0%      7  87.5%      10  71.4% 
Between 18 and 65 years      3  50.0%      1  12.5%      4  28.6% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  33.3%      5  62.5%      7  50.0% 
Male      4  66.7%      3  37.5%      7  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   6   8   14 


  Outcome Measures

1.  Primary:   Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Prince J. Kannankeril, MD, MSCI
Organization: Vanderbilt University Medical Center
phone: 615 322-7447
e-mail: prince.kannankeril@vanderbilt.edu


Publications:

Responsible Party: Prince Joseph Kannankeril, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01117454     History of Changes
Other Study ID Numbers: 100472
First Submitted: May 4, 2010
First Posted: May 5, 2010
Results First Submitted: February 22, 2017
Results First Posted: May 17, 2017
Last Update Posted: June 14, 2017