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IRCT20120520009801N11 IRCT 2024-02-04 Mashhad University of Medical Sciences Evaluation of the effect of Empagliflozin on the severity of heart failure symptoms and echocardiography parameters in patients with congenital heart diseases with left-to-right shunt Evaluation of the effect of Empagliflozin on the severity of heart failure symptoms and Ecocardiography parameters in patients with congenital heart diseases with left-to-right shunt: a triple-blind, randomized, placebo-controlled trial 2024-03-11 anticipated 44 Complete https://irct.ir/trial/75062 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign people to the study groups while guaranteeing the equality of the sample size of the groups, permuted block randomisation technique with blocks of size 6 and 2 is done using the website https://www.sealedenvelope.com. For example, the allocation result could be 11 blocks of 2 with different permutations. Type of randomization: Block Allocation Concealment: Using non-transparent sealed envelopes with a random sequence obtained from the random allocation step. Since our data will be completed over time and patients will gradually enter the study, patients are allocated to one of the control or intervention groups based on the time of entry into the study and also the sequence obtained in the randomisation stage. These codes are available to the researcher present at the hospital. It should be mentioned that this researcher is fully aware of the codes. Also, the drug or placebo is available to the researcher based on the code (A or B) and he is fully aware of which one is empagliflozin or placebo. The phone number of the researcher is also available to the patients who can call him whenever any problem arises. (This researcher is not involved in the prescription, nor in the treatment evaluation or data analysis, and is solely responsible for maintaining the codes and providing the medicine to the patients based on the random code determined by the doctor). The code assigned by him is recorded in the CRF form, Blinding description: After the codes were prepared and given to the researcher, if the criteria for entering the study are completed and based on the codes, the patient is randomly assigned to one of the groups. The relevant code is recorded in the CRF form and the researcher considers the medicine or placebo for the patient based on the assigned code. The patient is introduced to a nurse and the prescription of drugs is done by the nurse (therapist), meanwhile, after the patient takes the drug or placebo during the hospitalization period, the evaluator (doctor) who is different from the therapist (nurse) and does not know which medicine the patient has received and only knows the assigned code, performs the relevant evaluations. After recording, the results are given in the form of codes to the person to analyse the data and hence the data is also processed without the analyst knowing which medication is being prescribed to the patient and all information is recorded and stored confidentially without mentioning the name of the patient. 3 Congenital heart disease with left to right shunt causing heart failure symptoms. Intervention 1: Intervention group: ‏patients who receive empagliflozin tablets during hospitalization along with a standard drug regimen that includes ACEI/ARB, digoxin, and diuretics. Intervention 2: Control group: ‏patients who receive placebo during hospitalization along with a standard drug regimen that includes ACEI/ARB, digoxin, and diuretics. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Six months after the results are published To whom: People working in academic institutions Conditions: Use in clinic to improve disease severity, In the condition that safety and efficacy are confirmed in the study Where to obtain: Dr amirhoushang mohamadpour Email: Mohamadpoorah@mums.ac.ir How to obtain: Reply to email within a maximum of one week Comments:
public Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with congenital heart diseases with left-to-right shunt Heart failure One month to 18 years 1 month 18 years Both Patients with various types of cardiomyopathy Patients with myocarditis Patients with pericarditis and cardiac tamponade Patients with thiamine deficiency (beriberi) based on clinical symptoms Patients with severe anemia Patients with thyrotoxicosis Presence of pulmonary infection ‏Chronic kidney disease in GFR < 20 ml/min/173 m2 ‏Patients on dialysis Q21 Congenital malformations of cardiac septa Treatment - Drugs Placebo Intervention group: ‏patients who receive empagliflozin tablets during hospitalization along with a standard drug regimen that includes ACEI/ARB, digoxin, and diuretics Control group: ‏patients who receive placebo during hospitalization along with a standard drug regimen that includes ACEI/ARB, digoxin, and diuretics. TRPG (tricuspid regurgitation peak gradient). Timepoint: At the beginning and at the end of hospitalization. Method of measurement: Echocardiography. Left to Right shunt gradient. Timepoint: At the beginning and at the end of hospitalization. Method of measurement: Echocardiography. Left ventricular Ejection fraction. Timepoint: At the beginning and at the end of hospitalization. Method of measurement: Echocardiography. Heart failure symptoms. Timepoint: Daily. Method of measurement: Age-based Ross classification for heart failure in children. Vital signs. Timepoint: Daily. Method of measurement: Sphygmomanometer, Thermometer, Vital sign monitoring device , Nurse. Oxygen saturation (Spo2). Timepoint: Daily. Method of measurement: Pulse oximeter. Weight. Timepoint: Daily. Method of measurement: Scale. Inflammatory markers:CRP and ESR. Timepoint: At the beginning and at the end of hospitalisation. Method of measurement: laboratory tests. Mashhad University of Medical Sciences Approved 2023-10-21 Ethics committee of Mashhad University of Medical Sciences Vice Chancellor for Research and Technology, Third floor of Ghoreshi building, Next to Hoveyzeh Cinema, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)