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

Studying the effect of Ivabradine on the quality of life patients with heart failure with reduced EF

Randomized clinical trial, double-blind, placebo-controlled, phase 3 clinical trial on 90 patients. Random Allocation software was used for randomization.

This study will be conducted on patients over 18 years of age with heart failure with reduced ejection fraction, regardless of gender, who are referred to Shahid Madani Hospital in Tabriz. It is a placebo-controlled trial involving 90 patients, who will be randomly assigned to either the drug or placebo group using block randomization. The study is designed as a double-blind trial, meaning that neither the participants nor the researchers will be aware of whether the administered treatment is the actual drug or a placebo. The drug and placebo tablets will be identical in shape, size, color, taste, and packaging.

Inclusion criteria: diagnosis of heart failure with reduced EF less than 35%, over 18 years of age, use of the maximum dose of beta-blocker or the maximum tolerated dose, sinus rhythm on electrocardiogram, heart rate above 70 bpm, and having informed consent for participation in the study; Exclusion criteria: not having consent for participation in the study, pregnancy, and having any comorbid condition that significantly impairs quality of life

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. 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 based on Minnesota Living with Heart Failure Questionnaire (MLHFQ)

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.

Double-blinded The participants, the principal investigator, healthcare personnel (physicians and nurses), data collectors, and outcome assessors