Trial Outcomes & Findings for A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT) (NCT NCT04392362)

NCT ID: NCT04392362

Last Updated: 2021-06-25

Results Overview

The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: 10 seconds
• Results posted on: 2021-06-25

Participant Flow

Participant milestones

Measure	Intervention/SIM Group Giving adenosine 6mg premixed with saline flush to a total of 20ml and giving it as a rapid flush, then same method repeated twice with 12 mg adenosine if the SVT does not convert The group evaluated was the SIM or intervention group	Control/AHA Group Giving adenosine as 6mg in one syringe with a separate syringe with 20ml saline flush using a three way stop cock to connect the syringes. Adenosine is given first as a rapid push followed by another rapid flush from the saline. The same method to be repeated twice with 12 mg adenosine if the SVT does not convert after 10-15 seconds The group evaluated was the AHA or control group
Overall Study STARTED	23	7
Overall Study COMPLETED	23	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)

Baseline characteristics by cohort

Measure	Simplified Method n=23 Participants Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush Adenosine: A vial of adenosine with 6mg	AHA Method n=7 Participants Giving adenosine Ising the recommended AHA two syringe method Adenosine: A vial of adenosine with 6mg	Total n=30 Participants Total of all reporting groups
Age, Customized 18-59 years	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Age, Customized 60-80 years	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Race · White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Africa	23 Participants n=5 Participants	7 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 seconds

The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute.

Outcome measures

Measure	Intervention Group n=23 Participants Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush Adenosine: A vial of adenosine with 6mg	Control Group n=7 Participants Giving adenosine Ising the recommended AHA two syringe method Adenosine: A vial of adenosine with 6mg
The Number of Patients With First Dose Successful Termination of the Supraventricular Tachycardia to a Sinus Rhythm of Less Than 140 With the AHA Versus a Simplified Method of Adenosine Administration	13 participants	4 participants

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Group n=23 participants at risk Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush Adenosine: A vial of adenosine with 6mg	Control Group n=7 participants at risk Giving adenosine Ising the recommended AHA two syringe method Adenosine: A vial of adenosine with 6mg
Cardiac disorders Feeling of impending doom, dizziness	100.0% 23/23 • Number of events 23 • 2 hours There were no major adverse events	100.0% 7/7 • Number of events 7 • 2 hours There were no major adverse events

Additional Information

Dr. Amanda Makhubela

University of Pretoria

Phone: 0722746091

Email: neurosurgeon76@gmail.com

Results disclosure agreements

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