Congenital Mitral Insufficiency
Conditions
Keywords
congenital heart disease, mitral regurgitation, mitral valve repair postoperative, drug therapy
Brief 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 after mitral repair. The main questions it aims to answer are: * Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients after mitral repair? * 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.
Interventions
0.3mg/kg, tid
0.2mg/kg, bid
2-4mg/kg, bid
0.2-0.5mg/mg, bid
0.06g/kg, tid
Sponsors
Shanghai Children's Medical Center
Chinese Academy of Medical Sciences, Fuwai Hospital
Guangzhou Women and Children's Medical Center
Children's Hospital of Chongqing Medical University
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No
Inclusion criteria
* under 14 years old * after mitral valve repair
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the recurrence rate of moderate to severe mitral valve regurgitation | after 12 months of treatment | During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in symptoms | after 12 months of treatment | Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms. |
| Improvement in left ventricular function | after 12 months of treatment | Based on the echocardiogram, measurements are taken for left ventricular ejection fraction, left ventricular fractional shortening, left ventricular end-diastolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic diameter, and left ventricular end-systolic volume. |
| NT-proBNP level | after 12 months of treatment | The trend in NT-proBNP levels. |
| Incidence rate of drug adverse reactions | after 12 months of treatment | The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes. |
Countries
China
Contacts
Primary ContactKai Ma, PhD
Backup ContactZheng Dou, PhD
Outcome results
None listed