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IRCT20180722040556N11 IRCT 2025-01-20 Esfahan University of Medical Sciences Comparison of the effect of sacubitril/valsartan with enalapril in the prevention of cardiotoxicity caused by the co-treatment of doxorubicin and trastuzumab in patients with breast cancer: a randomized and controlled clinical trial Comparison of the effect of sacubitril/valsartan with enalapril in the prevention of cardiotoxicity caused by the co-treatment of doxorubicin and trastuzumab in patients with breast cancer: a randomized and controlled clinical trial 2025-02-18 anticipated 86 Complete https://irct.ir/trial/81290 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This study is a clinical trial. It is anticipated that sample collection will take place over a two-year period (in the years 2024 and 2025) on hospitalized or outpatient patients at the Cardiovascular Research Institute of Isfahan (affiliated with Isfahan University of Medical Sciences) and at the Seyed Al-Shohada Hospital clinic, Randomization description: The randomization of samples will be conducted based on the block randomization method. The sampling method involves entering information such as the number of treatment groups, block sizes (multiples of the number of groups), and the total number of patients into online software designed for this calculation. Based on the codes obtained from the final analysis, the type of medication received by each patient will be determined. In this study, since there are two treatment groups, blocks of 4 (a multiple of 2) will be used. The anticipated sample size of patients will be randomly divided into two groups: those receiving sacubitril/valsartan and those receiving enalapril, using this sampling method. In this way, according to the order of patient enrollment in the study (based on inclusion criteria), each patient will be assigned a code, and then based on the treatment group assigned to that code in the software output, the patient will be placed in one of the treatment groups for sacubitril/valsartan or enalapril, Blinding description: To ensure the blinding of the study, a clinical pharmacy specialist will design random codes using the relevant online software and inform the clinical pharmacy resident which patient, identified by a specific number, will receive which medication. The medications will then be prepared by the research team, and based on the code assigned to each patient, the prescribed medication will be provided for three months at the outset. During this three-month period, since the patient is under the supervision of the oncologist at Seyed Al-Shohada Center, the clinical pharmacy resident will monitor the patient and ensure adherence to the medication protocol according to the research study plan. When patients visit the relevant clinics, they will be screened by the research team. If they qualify for entry into the study, they will receive a code based on the randomization process and will collect their medication from the clinical pharmacy resident. The physician responsible for conducting the baseline and three-month echocardiograms (the study physician) will not have any information about the patient's code or the medication being administered. The echocardiographic images and data will be provided to the analyzing physician without mentioning the received medication, solely assigned with a random code for each patient. 3 Breast cancer patients. Intervention 1: Intervention Group: Patients with HER2-positive breast cancer undergoing AC treatment will receive Sacubitril/Valsartan at a daily dose of 50 mg for a minimum of three months. These patients are at risk of heart failure due to the use of cardiotoxic medications, and the aim of this intervention is to evaluate the impact of this medication on reducing cardiac complications resulting from cancer treatments. After obtaining informed consent and identification by the interventionist, the medication will be administered randomly and without the patient's knowledge to prevent any bias in the results. Throughout the study, compliance with medication intake will be closely monitored, and if less than 80% compliance is observed, the patient will be withdrawn from the study to ensure the validity of the final data. Additionally, side effects and clinical changes in patients will be regularly monitored. Intervention 2: Control Group: Patients with HER2-positive breast cancer undergoing AC treatment will receive Enalapril at a daily dose of 5 mg for a minimum of three months. This group also consists of patients who are at risk of heart failure due to cardiotoxic medications, and the purpose of administering Enalapril is to compare its effects with those of Sacubitril/Valsartan in reducing cardiac complications. Similar to the intervention group, after obtaining informed consent and identification, the medication will be administered randomly and without the patient's knowledge. Compliance with medication intake will also be closely monitored, and if less than 80% compliance is observed, the patient will be withdrawn from the study. Furthermore, side effects and clinical changes in these patients will also be regularly monitored to determine the actual impact of treatment on their heart health. Yes - There is a plan to make this available What will be shared: All collected data When: From May 2026 To whom: All academic centers Conditions: All documents with citation Where to obtain: Email address How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week. Comments:
public Azadeh Moghaddas
Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences scientific Azadeh Moghaddas
Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adult patients newly diagnosed with HER2-positive breast cancer who have not received any anthracycline-containing chemotherapy regimen in the past. These patients are to be treated with an AC regimen containing 60 mg/m² of doxorubicin and 600 mg/m² of cyclophosphamide for 4-6 cycles, followed by treatment with trastuzumab. Patients are expected to receive at least three cycles of trastuzumab (typically 6 mg/kg every three weeks) alone or in combination with or after a taxane-containing regimen if necessary, following the doxorubicin regimen. Study participants must have a baseline left ventricular ejection fraction (EF) of at least 50% (≥50%). They should have no history of cardiovascular diseases such as heart failure, angina, or hypertension. The patient must provide consent to participate in the study and cooperate with the protocol, which includes a monitoring period of at least three months. 18 years no limit Female Patients with a systolic blood pressure of less than 100 mmHg. Patients with contraindications to the use of ACE inhibitors, ARBs, and neprilysin inhibitors. Patients who experience potential side effects or allergic reactions to sacubitril/valsartan or enalapril during treatment. Patients with renal failure with a GFR of less than 45 ml/min/1.73 m². Patients with serum potassium levels higher than 5 mmol/L. Patients who have experienced adverse effects such as angioedema or cough from taking enalapril or other ACE inhibitors. Patients who develop another serious illness during the intervention and are required to receive various medications that affect the cardiovascular system. C50 Malignant neoplasm of breast Prevention Prevention Intervention Group: Patients with HER2-positive breast cancer undergoing AC treatment will receive Sacubitril/Valsartan at a daily dose of 50 mg for a minimum of three months. These patients are at risk of heart failure due to the use of cardiotoxic medications, and the aim of this intervention is to evaluate the impact of this medication on reducing cardiac complications resulting from cancer treatments. After obtaining informed consent and identification by the interventionist, the medication will be administered randomly and without the patient's knowledge to prevent any bias in the results. Throughout the study, compliance with medication intake will be closely monitored, and if less than 80% compliance is observed, the patient will be withdrawn from the study to ensure the validity of the final data. Additionally, side effects and clinical changes in patients will be regularly monitored. Control Group: Patients with HER2-positive breast cancer undergoing AC treatment will receive Enalapril at a daily dose of 5 mg for a minimum of three months. This group also consists of patients who are at risk of heart failure due to cardiotoxic medications, and the purpose of administering Enalapril is to compare its effects with those of Sacubitril/Valsartan in reducing cardiac complications. Similar to the intervention group, after obtaining informed consent and identification, the medication will be administered randomly and without the patient's knowledge. Compliance with medication intake will also be closely monitored, and if less than 80% compliance is observed, the patient will be withdrawn from the study. Furthermore, side effects and clinical changes in these patients will also be regularly monitored to determine the actual impact of treatment on their heart health. The extent of changes in left ventricular systolic function before and after the intervention. Timepoint: Before the intervention began and after three months of taking either enalapril or sacubitril/valsartan. Method of measurement: Examination of echocardiographic indices including GLS and assessment of cardiac troponin enzyme. Esfahan University of Medical Sciences Approved 2024-11-25 Ethics committee of Isfahan university of medical sciences Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)