Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-01-01
2024-12-31
Brief Summary
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The main questions it aims to answer are:
* Can a modified drug therapy improve left ventricular function in pediatric heart failure patients?
* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).e Traditional Drug Therapy Group
Captopril Tablets
0.3mg/kg, tid
Metoprolol Oral Tablet
0.2mg/kg, bid
Spironolactone Tablets
2-4mg/kg, bid
Torsemide Tablets
0.2-0.5mg/mg, bid
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).
Torsemide Tablets
0.2-0.5mg/mg, bid
Potassium citrate powder
0.06g/kg, tid
Interventions
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Captopril Tablets
0.3mg/kg, tid
Metoprolol Oral Tablet
0.2mg/kg, bid
Spironolactone Tablets
2-4mg/kg, bid
Torsemide Tablets
0.2-0.5mg/mg, bid
Potassium citrate powder
0.06g/kg, tid
Eligibility Criteria
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Inclusion Criteria
* heart failure after congenital heart surgery
* Ross \> 2 or NYHA \> 2
* LVEF\<55%, or LVFS\<25%
Exclusion Criteria
* congenital heart disease without anatomical correction
* 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
* Refuse to sign the informed consent or refuse to participate in this experiment
14 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Beijing Children's Hospital
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Shoujun Li
Director of Congenital Heart Surgery Center
Principal Investigators
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Shoujun Li, MD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-1-4032-1
Identifier Type: -
Identifier Source: org_study_id
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