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IRCT20120520009801N12 IRCT 2024-02-19 Mashhad University of Medical Sciences Evaluation of the effect of Allopurinol on the frequency of ventricular and supraventricular arrhythmias Evaluation of the effect of Allopurinol on the frequency of ventricular and supraventricular arrhythmias in patients with an implantable cardioverter-defibrillator 2024-04-02 anticipated 134 Complete https://irct.ir/trial/74778 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Condition 1: Ventricular arrhythmias. Condition 2: Supraventricular arrhythmia. Intervention 1: Intervention group: Allopurinol 300 mg tablets, Hakim Pharmaceuticals, once a day for three months (67 people). Intervention 2: Control group: Placebo tablets made by the School of Pharmacy of Mashhad University of Medical Sciences, one daily for 3 months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: starting 6 months after publication To whom: People working in academic institutions Conditions: The use of data is unimpeded by mentioning the source. Where to obtain: Dr. AmirHoushang Mohamadpour Mail: mohamadpoorah@mums.ac.ir Phone: 09153162909 How to obtain: Reply to email within a maximum of one week Comments:
public Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 I47.0 I47.1 Re-entry ventricular arrhythmia Supraventricular tachycardia Prevention Placebo Intervention group: Allopurinol 300 mg tablets, Hakim Pharmaceuticals, once a day for three months (67 people) Control group: Placebo tablets made by the School of Pharmacy of Mashhad University of Medical Sciences, one daily for 3 months 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. 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. Uric acid level. Timepoint: Before the intervention and after 3 months. Method of measurement: Biochemistry test of the patient's blood sample. Blood pressure. Timepoint: Before the intervention and after 3 months. Method of measurement: sphygmomanometer. Hospitalization. Timepoint: Before the intervention and after 3 months. Method of measurement: Pulse oximeter device. Mashhad University of Medical Sciences Approved 2024-01-02 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research and Technology, Third floor of Ghoreshi building, Next to Hoveyzeh Cinema, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)