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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120520009801N11

Enrollment

Registered

2024-02-04

Start date

2024-03-11

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Age

1 Months to 18 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hooshang Mohammadpour

Mashhad University of Medical Sciences

mohamadpoorah@mums.ac.ir+98 51 1882 3255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026