Effect of Sacubitril-Valsartan versus angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blocker (ARB) on left ventricular ejection fraction in patient with heart failure: a double-blind randomized clinical trial

To assess the effect of Sacubitril-Valsartan versus angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blocker (ARB) on left ventricular ejection fraction in patient with heart failure

This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.

This study will be conducted at the Farshchian Heart Hospital in Hamadan city, involving 225 eligible patients with heart failure. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.

Inclusion criteria: Age 18 to 80 years Heart failure Exclusion criteria: Severe coronary disease Valvular heart disease Pulmonary thromboembolism Congenital heart disease

Intervention group 1: Sacubitril-valsartan tablets 24/26 mg every 12 hours for 6 months Intervention group 2: Angiotensin converting enzyme inhibitor (ACEI) 12/5 mg every 12 hours for 6 months Intervention group 3: Angiotensin receptor blocker (ARB) 12/5 mg every 12 hours for 6 months

Primary outcome: Average blood pressure, mean serum creatinine, the average quality of life score, left heart ejection fraction, the frequency and duration of hospitalization, the occurrence of death

In this study, random assignment of patients to the intervention and control groups will be performed using block randomization. To achieve this, six sheets of paper will be prepared - two with the name of "Intervention 1," two with the name of "Intervention 2," and two with the name of "Control." These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.

The medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study.