Evaluation of the effect of Allopurinol on the frequency of ventricular and supraventricular arrhythmias in patients with an implantable cardioverter-defibrillator
Determining the effect of allopurinol on the frequency of ventricular and supraventricular arrhythmias in patients with implantable cardiac defibrillators.
Design
A clinical trial with a control group, with a parallel group,double-blind, randomized, phase 3 on 134 patients. The site https://www.sealedenvelope.com/ was used for randomization.
Settings and conduct
This study is conducted on 134 eligible patients in a private doctor's office located in Mashhad.
The study is done in a double-blind manner, and the patient, the researcher and the analyst are blind.
Medicine and placebo are divided into two groups, A and B, and are given to participating patients randomly in a closed block.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients with implantable cardiac defibrillators who visit the doctor's office on an outpatient basis and have informed consent to participate in the clinical trial.
The main Exclusion criteria are history of Allopurinol, class I and III antiarrhythmic or anti-inflammatory drugs; moderate to severe kidney dysfunction; significant liver dysfunction.
Intervention groups
In the drug receiving group, patients receive one 300 mg allopurinol tablet daily and in the placebo group, one placebo tablet daily for 3 months.
Main outcome variables
Frequency of ventricular and supraventricular arrhythmias
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120520009801N12
Registration date:2024-02-19, 1402/11/30
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Amir Hooshang Mohammadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohamadpoorah@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Allopurinol on the frequency of ventricular and supraventricular arrhythmias in patients with an implantable cardioverter-defibrillator
Public title
Evaluation of the effect of Allopurinol on the frequency of ventricular and supraventricular arrhythmias
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years and less than 70 years
Having an implantable cardioverter-defibrillator for more than 3 months before starting participation in the clinical trial
Obtain informed consent from the patient
Exclusion criteria:
Taking the drug allopurinol before
Moderate to severe kidney dysfunction (GFR < 60 ml/min/1.73m2)
Significant impairment of liver function (Child-Pugh class B or C)
Previous history of severe skin reactions like Steven Johnson
Pregnancy or suspected pregnancy
Active inflammation or infection
Suffering from autoimmune diseases and malignancies
Taking class I and III antiarrhythmic drugs
Performing major surgeries
Taking any medication with anti-inflammatory effect
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
The method used to generate a random allocation sequence with the guarantee of equal allocation of people to two groups is a permutation block that is created using the website https://www.sealedenvelope.com/. With the explanation that 34 blocks of 4 will be randomly generated and patients will be assigned to two study groups based on the sequence obtained from the above blocks. With the explanation that each of the blocks has 4 members and the shape of the blocks is as follows:
[AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB]
Code A corresponds to the intervention group and code B corresponds to the control group. Therefore, 34 quadruple blocks have been randomly created by the site, and patients are assigned to two study groups based on the sequence obtained from the above blocks.
Allocation concealment method is by using non-transparent sealed envelopes with random sequence obtained from the random allocation step.
Blinding (investigator's opinion)
Double blinded
Blinding description
A and B codes are given to the drug and placebo group and these codes are available to the researcher in the doctor's office. It should be noted that this researcher is fully aware of the types of codes. Also, the drugs are given to him based on the number (A or B) and he is fully aware of which drug is allopurinol or placebo.
It should be noted that the placebo sample made by the Pharmaceutics Laboratory of the Faculty of Pharmacy is completely similar to allopurinol tablets, and therefore patients do not know whether they are in the drug or placebo group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Third floor of Ghoreshi building, Next to Hoveyzeh Cinema, Daneshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-01-02, 1402/10/12
Ethics committee reference number
IR.MUMS.REC.1402.276
Health conditions studied
1
Description of health condition studied
Ventricular arrhythmias
ICD-10 code
I47.0
ICD-10 code description
Re-entry ventricular arrhythmia
2
Description of health condition studied
Supraventricular arrhythmia
ICD-10 code
I47.1
ICD-10 code description
Supraventricular tachycardia
Primary outcomes
1
Description
Frequency of ventricular arrhythmias
Timepoint
The beginning of the study and 3 months later
Method of measurement
Examining the data obtained from the implantable cardiac defibrillator device
2
Description
Frequency of supraventricular arrhythmias
Timepoint
The beginning of the study and 3 months later
Method of measurement
Examining the data obtained from the implantable cardiac defibrillator device
Secondary outcomes
1
Description
Uric acid level
Timepoint
Before the intervention and after 3 months
Method of measurement
Biochemistry test of the patient's blood sample
2
Description
blood pressure
Timepoint
Before the intervention and after 3 months
Method of measurement
sphygmomanometer
3
Description
Hospitalization
Timepoint
Before the intervention and after 3 months
Method of measurement
Pulse oximeter device
Intervention groups
1
Description
Intervention group: Allopurinol 300 mg tablets, Hakim Pharmaceuticals, once a day for three months (67 people)
Category
Prevention
2
Description
Control group: Placebo tablets made by the School of Pharmacy of Mashhad University of Medical Sciences, one daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Tayyebi's office
Full name of responsible person
Mohammad Tayyebi
Street address
No. 11, between Besat 1 and 3, Molla Sadra and Besat intersection, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3847 8514
Email
TayyebiM@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, third floor of Ghoreshi building, next to Hoveyzeh Cinema, University Street, Mashhad