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IRCT20230618058519N1 IRCT 2023-08-16 Tehran heart center Evaluating the efficacy of Ivabradine in reducing the frequency of PAC , in patients with symptomatic frequent PACs Evaluating the clinical efficacy of adding Ivabradine to the standard treatment in reducing the frequency of premature atrial complexes (PAC) in ECG holter comparing to the standard treatment , in patients with symptomatic frequent premature atrial complexes (PAC) 2023-07-06 anticipated 100 Complete https://irct.ir/trial/70807 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study is a randomized clinical trial which will be single center. Randomization will be done by the method of permuted block with randomized blocks of double, quadruple and sextet. For complying the allocation concealment, a web based method will be used. 3 Frequent premature atrial complex (PAC). Intervention 1: Intervention group: Patients in intervention group use Ivabradine 5mg twice daily for 2 weeks. All of the patients in both groups, receive metoprolol 25mg BID as the standard treatment. Intervention 2: Control group: In control group patients only use the standard treatment as metoprolol 25mg BID for 2 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information is available.
public Dr Layla Nematipour
Tehran Heart Henter, Corner of Jalaal-Al-Ahmad Expressway, North Kaargar Ave.
Tehran Iran (Islamic Republic of) 1313814117 +98 21 8802 9600 l.nematipour@gmail.com Tehran heart center scientific Dr Layla Nematipour
Tehran Heart Henter, Corner of Jalaal-Al-Ahmad Expressway, North Kaargar Ave.
Tehran Iran (Islamic Republic of) 1313814117 +98 21 8802 9600 l.nematipour@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patient in ages between 18-75 years. PAC frequency in ECG holter be between 5-10 % (average of 8%). Patients who have the ability to understand and sign the letter of satisfaction. 18 years 75 years Both Patient have the history of using Ivabradine during last 2 months. Patients having cardiovascular disorders. Patients having congenital long QT or QT>500 msec at the beginning of study. using drugs with reducing heart rate effect, which have major interactions with Ivabradine. Patients whom are pregnant or lactating or tending to become pregnant. Patients suffering from advanced liver disease (class C of Child-Pugh score). Patient having the history of using Ivabradine, whom has had discontinued Ivabradine because of adverse effects. Patient having AF rhythm. I49.1 Atrial premature depolarization Treatment - Drugs Treatment - Drugs Intervention group: Patients in intervention group use Ivabradine 5mg twice daily for 2 weeks. All of the patients in both groups, receive metoprolol 25mg BID as the standard treatment. Control group: In control group patients only use the standard treatment as metoprolol 25mg BID for 2 weeks. Frequency of PAC in 24 hours ECG holter. Timepoint: To understand the effect of Ivabradine on reducing the frequency of PAC, further holter will be done on 12th day of study for 24 hours. Method of measurement: ECG holter. Rate of reduction in PAC frequency in ECG holter. Timepoint: To understand the effect of Ivabradine on reducing the frequency of PAC, further holter will be done on 12th day of study for 24 hours. Method of measurement: 24 hours ECG holter. Symptoms of patients with symptomatic frequent PACs. Timepoint: To understand the effect of Ivabradine on reducing the frequency of PAC, further holter will be done on 12th day of study for 24 hours. Method of measurement: 24 hours ECG holter. Tehran heart center Approved 2023-07-15 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Keshavarz Blvd, Intersection of Qods Ave Tehran Tehran Iran (Islamic Republic of)