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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
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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:
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.
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| 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). |
| |
| the 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 |
| Change in left ventricular ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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Children under the age of 14 with moderate to severe mitral valve regurgitation, without contraindications for mitral valve repair, and without an immediate need for 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 |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D002216 | Captopril |
| D008790 | Metoprolol |
| D013148 | Spironolactone |
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| Children's Hospital of Chongqing Medical University |
| OTHER |
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| 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. |
| after 12 months of treatment |
| Change in left ventricular end-diastolic diameter | Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter. | 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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006349 | Heart Valve Diseases |
| 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 |