Study of Drug Therapy for Pediatric Heart Failure

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Heart Failure Congenital

Treatments: Drug: Captopril Tablets; Drug: Metoprolol Oral Tablet; Drug: Torsemide Tablets; Drug: Spironolactone Tablets; Drug: Potassium citrate powder

Study type: Observational

Funder types: Other

Identifiers

NCT06039540

2022-1-4032-1

Details and patient eligibility

About

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients.

The main questions it aims to answer are:

• Can a modified drug therapy improve left ventricular function in pediatric heart failure patients?
• Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients younger than 14 years of age
• heart failure after congenital heart surgery
• Ross > 2 or NYHA > 2
• LVEF<55%, or LVFS<25%

Exclusion criteria

• single ventricle
• congenital heart disease without anatomical correction
• Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
• Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U)
• Patients with severe liver and kidney failure
• Patients who are allergic to related medications
• Patients with symptomatic hypotension who cannot tolerate related drugs
• Refuse to sign the informed consent or refuse to participate in this experiment

Trial design

200 participants in 2 patient groups

Modified Drug Therapy Group

Description:

Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group

Treatment:

Drug: Potassium citrate powder

Drug: Metoprolol Oral Tablet

Drug: Captopril Tablets

Drug: Spironolactone Tablets

Drug: Torsemide Tablets

Traditional Drug Therapy Group

Description:

Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).

Treatment:

Drug: Potassium citrate powder

Drug: Torsemide Tablets