Trial Outcomes & Findings for Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia (NCT NCT00390546)

NCT ID: NCT00390546

Last Updated: 2017-12-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 72 participants
• Primary outcome timeframe: 6 months or until study endpoints were reached
• Results posted on: 2017-12-13

Participant Flow

Patients were enrolled between December 2006 and August 2010. 14 centers enrolled study participants. Only 72 of the desired 220 subjects enrolled. Enrolment closed early as an independent, unblinded verification of the results determined that a much larger sample size than estimated was necessary to demonstrate the primary outcome existed.

Participant milestones

Measure	Digoxin The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.	Propranolol The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
Overall Study STARTED	33	39
Overall Study COMPLETED	27	34
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Digoxin The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.	Propranolol The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
Overall Study Renal impairment	1	0
Overall Study Physician Decision	5	5

Baseline Characteristics

Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia

Baseline characteristics by cohort

Measure	Digoxin n=32 Participants The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.	Propranolol n=39 Participants The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.	Total n=71 Participants Total of all reporting groups
Age, Continuous	16.5 days n=93 Participants	7 days n=4 Participants	11.75 days n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	15 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	24 Participants n=4 Participants	47 Participants n=27 Participants
Race/Ethnicity, Customized White	25 participants n=93 Participants	34 participants n=4 Participants	59 participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latino	2 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants
Race/Ethnicity, Customized Black	3 participants n=93 Participants	1 participants n=4 Participants	4 participants n=27 Participants
Race/Ethnicity, Customized Native American	2 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants
Race/Ethnicity, Customized Other	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months or until study endpoints were reached

Outcome measures

Measure	Digoxin n=32 Participants The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.	Propranolol n=39 Participants Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.	12 percentage of participants	18 percentage of participants

SECONDARY outcome

Timeframe: up to 110 days of treatment

Infants treated with propranolol or digoxin

Outcome measures

Measure	Digoxin n=32 Participants The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.	Propranolol n=39 Participants Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
Number of Treated Patients Experiencing First SVT Recurrence	6 participants	12 participants Interval 0.6 to 4.26

SECONDARY outcome

Timeframe: 12 months

In relation to the study drugs

Outcome measures

Measure	Digoxin n=32 Participants The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.	Propranolol n=39 Participants Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin	0 participants	0 participants

Adverse Events

Digoxin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propranolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shubhayan Sanatani

University of British Columbia

Phone: 604-875-2345

Email: ssanatani@cw.bc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place