Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-12-31

Brief Summary

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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:

* 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.

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Detailed Description

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Conditions

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Congenital Mitral Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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).

Captopril Tablets

Intervention Type DRUG

0.3mg/kg, tid

Metoprolol Oral Tablet

Intervention Type DRUG

0.2mg/kg, bid

Spironolactone Tablets

Intervention Type DRUG

2-4mg/kg, bid

Torsemide Tablets

Intervention Type DRUG

0.2-0.5mg/mg, bid

Potassium citrate powder

Intervention Type DRUG

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).

Torsemide Tablets

Intervention Type DRUG

0.2-0.5mg/mg, bid

Potassium citrate powder

Intervention Type DRUG

0.06g/kg, tid

Interventions

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Captopril Tablets

0.3mg/kg, tid

Intervention Type DRUG

Metoprolol Oral Tablet

0.2mg/kg, bid

Intervention Type DRUG

Spironolactone Tablets

2-4mg/kg, bid

Intervention Type DRUG

Torsemide Tablets

0.2-0.5mg/mg, bid

Intervention Type DRUG

Potassium citrate powder

0.06g/kg, tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \< 14 years old
* had not undertake mitral valve surgery before
* moderate to severe mitral regurgitation

Exclusion Criteria

* moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
* concommitant with mitral stenosis
* ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
* Barlow syndrome
* dysplasia of mitral leaflet
* complete/Partial endocardial cushion defect
* common atrioventricular valve
* atrioventricular common channel
* cardiomyopathy
* other mitral valve surgery contraindications
* moderate to severe mitral regurgitation requires mitral valve surgery

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No