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

June 3, 2021 updated by: Amanda Makhubela, MD, University of Pretoria

A Randomised Controlled Trial of the Standard Versus a Simplified Adenosine Administration Method in the Treatment of Adult Patients With Supra- Ventricular Tachycardia (SVT)

Study to compare non inferiority of giving adenosine with the simplified method vs the AHA method

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

tle: A randomised controlled trial of the standard versus a simplified adenosine administration method in the treatment of adult patients with supra- ventricular tachycardia (SVT

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Steve Biko hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Svt
  • normal blood pressure
  • normal mentation
  • Give consent

Exclusion Criteria:

  • recent coffee
  • Allergy to adenosine
  • Asthma
  • cardiac operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group
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
Drug: Adenosine
A vial of adenosine with 6mg
ACTIVE_COMPARATOR: Control group
Giving adenosine Ising the recommended AHA two syringe method
Drug: Adenosine
A vial of adenosine with 6mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 10 seconds
The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute.
10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pretoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

December 16, 2020

Study Completion (ACTUAL)

December 16, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (ACTUAL)

May 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPretoria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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