Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

Summary

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.

Conditions

• Congenital Mitral Insufficiency

Interventions

DRUG

Captopril Tablets

0.3mg/kg, tid

DRUG

Metoprolol Oral Tablet

0.2mg/kg, bid

DRUG

Spironolactone Tablets

2-4mg/kg, bid

DRUG

Torsemide Tablets

0.2-0.5mg/mg, bid

DRUG

Potassium citrate powder

0.06g/kg, tid

Sponsors & Collaborators

• Shanghai Children's Medical Center

  collaborator OTHER

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• China National Center for Cardiovascular Diseases

  lead OTHER_GOV

Principal Investigators

• Shoujun Li, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-01

Primary Completion

2024-08-09

Completion

2024-12-31

FDA Drug

Yes

Countries

• China

Study Locations