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

Phase 3

• Conditions: Congenital heart disease with left to right shunt causing heart failure symptoms.; Congenital malformations of cardiac septa

• Registration Number: IRCT20120520009801N11
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients with congenital heart diseases with left-to-right shunt
Heart failure
One month to 18 years

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.