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IRCT20250518065795N1 IRCT 2025-07-07 Tabriz University of Medical Sciences The effect of ivabradine on the quality of life in patients with heart failure with reduced ejection fraction Studying the effect of ivabradine on the quality of life in patients with heart failure with reduced ejection fraction: a double-blind, placebo-controlled randomized clinical trial 2025-09-11 anticipated 90 Complete https://irct.ir/trial/83635 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study is a double-blind, placebo-controlled randomized clinical trial. Patients will be assigned to either the intervention or placebo group using "Block Randomization" based on computer-generated numbers produced by the "Random Allocation" software. In this software, the total number of groups and total sample size will be defined, then within each block, the randomization option will be executed. Next, a list of computer-generated numbers will be provided to the physician, and the physician will allocate patients to the groups according to the sequence determined by the software for group assignment, Blinding description: Double-blinded The participants, the principal investigator, healthcare personnel (physicians and nurses), data collectors, and outcome assessors. 3 Heart failure with reduced ejection fraction. Intervention 1: The intervention group will receive Ivabradine tablets (5 mg every 12 hours) for one month in addition to their routine treatments to evaluate its effect on their quality of life. Intervention 2: Control group: The control group will receive placebo tablets (identical in appearance, every 12 hours) for one month in addition to their routine treatments to assess its impact on their quality of life. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The participant data file is not currently available, but a decision regarding it will be made in the later stages of the study if necessary.
public Dr. Reza Noori
Shahid Madani Hospital., Daneshgah Ave., Tabriz, Iran.
Tabriz Iran (Islamic Republic of) 5163639889 +98 41 3337 3900 dr.noori_r@yahoo.com Tabriz University of Medical Sciences scientific Dr. Mohammad Reza Taban Sadeghi
Shahid Madani Hospital., Daneshgah Ave., Tabriz, Iran.
Tabriz Iran (Islamic Republic of) 5163639889 +98 41 3337 3900 taban@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) A confirmed diagnosis of heart failure with reduced ejection fraction with an ejection fraction of less than 35% Use of the maximum dose of beta-blocker or the maximum tolerated dose Sinus rhythm on electrocardiogram Heart rate above 70 bpm Informed consent for participation in the study At least 18 years old 18 years no limit Both Not having consent for participation in the study Pregnancy Having any comorbid condition that impairs quality of life I50.1 Left ventricular failure Treatment - Drugs Treatment - Drugs The intervention group will receive Ivabradine tablets (5 mg every 12 hours) for one month in addition to their routine treatments to evaluate its effect on their quality of life. Control group: The control group will receive placebo tablets (identical in appearance, every 12 hours) for one month in addition to their routine treatments to assess its impact on their quality of life. Quality of life score. Timepoint: At baseline (before the start of the intervention) and one month after initiation of treatment. Method of measurement: Minnesota Living with Heart Failure Questionnaire (MLHFQ). Tabriz University of Medical Sciences Approved 2025-04-28 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)