Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Congenital Mitral Insufficiency

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

Study type: Observational

Funder types: Other

Identifiers

NCT06037434

2022-GSP-GG-19-1

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 patients with mild to moderate mitral valve regurgitation.

The main questions it aims to answer are:

• Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?
• 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 one-year 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 3 months, 6 months, and 12 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 12 months of treatment, is lower in the former than in the latter.

Enrollment: 122 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• < 14 years old
• had not undertake mitral valve surgery before
• moderate to severe mitral regurgitation

Exclusion criteria

• moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
• concommitant with mitral stenosis
• ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
• Barlow syndrome
• dysplasia of mitral leaflet
• complete/Partial endocardial cushion defect
• common atrioventricular valve
• atrioventricular common channel
• cardiomyopathy
• other mitral valve surgery contraindications
• moderate to severe mitral regurgitation requires mitral valve surgery

Trial design

122 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).

Treatment:

Drug: Captopril Tablets

Drug: Metoprolol Oral Tablet

Drug: Potassium citrate powder

Drug: Torsemide Tablets

Drug: Spironolactone Tablets

the 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