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

Improving the severity of heart failure symptoms and echocardiographic parameters in CHD patients with left-to-right shunt by administering empagliflozin

A triple blind, randomised, placebo-controlled clinical trial, prospective study, superiority, parallel, phase 3, performed on 44 patients, for randomisation permuted block randomisation technique with blocks of size 6 and 2 is done using the website https://www.sealedenvelope.com.

44 patients with heart failure caused by congenital defects of the heart septum who are admitted to the paediatric cardiology department of Imam Reza Hospital are included in the study. Patients are randomly assigned to 2 groups intervention and control, in triple-blind manner, by assigning codes A and B to the drug and placebo groups, which only the nurse knows about the type of codes. During hospitalisation primary and secondary outcomes are evaluated.

Inclusion criteria: CHD patients with left-to-right shunt and heart failure aged one month to 18 years Exclusion criteria: patients with various types of cardiomyopathy myocarditi, pericarditis and cardiac tamponade thiamine deficiency severe anemia thyrotoxicosis ,pulmonary infection CKD (GFR < 20 ml/min/m2) dialysis

The intervention group includes patients who receive empagliflozin tablets during hospitalization along with a standard drug regimen that includes ACEI/ARB, digoxin, and diuretics. The control group includes patients who receive placebo during hospitalization along with a standard drug regimen that includes ACEI/ARB, digoxin, and diuretics. Finally, the severity of heart failure symptoms and echocardiography parameters in two groups are compared.

Echocardiography parameters: TRPG (tricuspid regurgitation peak gradient) Left to Right shunt gradient Left ventricular Ejection fraction

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.

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.

All data is potentially shareable after unidentifiable individuals

Six months after the results are published

People working in academic institutions

Use in clinic to improve disease severity, In the condition that safety and efficacy are confirmed in the study

Dr amirhoushang mohamadpour Email: Mohamadpoorah@mums.ac.ir

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