Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Drug Therapy Group | 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). |
| |
| Traditional Drug Therapy Group | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Captopril Tablets | Drug | 0.3mg/kg, tid |
| |
| Metoprolol Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| the recurrence rate of moderate to severe mitral valve regurgitation | 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. | after 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in symptoms | 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. | after 12 months of treatment |
| Improvement in left ventricular function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Children under the age of 14 after mitral valve repair surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Ma, PhD | Contact | +86 15901428497 | drmakaifw@yahoo.com | |
| Zheng Dou, PhD | Contact | +86 18810673618 | drdouzheng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shoujun Li, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Children's Hospital of Chongqing Medical University |
| OTHER |
Not provided
Not provided
Not provided
| Drug |
0.2mg/kg, bid |
|
| Spironolactone Tablets | Drug | 2-4mg/kg, bid |
|
| Torsemide Tablets | Drug | 0.2-0.5mg/mg, bid |
|
| Potassium citrate powder | Drug | 0.06g/kg, tid |
|
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. |
| after 12 months of treatment |
| NT-proBNP level | The trend in NT-proBNP levels. | after 12 months of treatment |
| Incidence rate of drug adverse reactions | The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes. | after 12 months of treatment |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006349 | Heart Valve Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002216 | Captopril |
| D008790 | Metoprolol |
| D013148 | Spironolactone |
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D007783 | Lactones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided