Clinical trial NCT06037434: Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
Official title: A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Drug Therapy for Pediatric Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Mitral Insufficiency
Keywords: congenital heart disease
mitral regurgitation
drug therapy
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Children's Medical Center
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Guangzhou Women and Children's Medical Center
name: Children's Hospital of Chongqing Medical University
First posted: 2023-09-14
Enrollment: 122
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: the recurrence rate of moderate to severe mitral valve regurgitation
timeFrame: after 12 months of treatment
Secondary outcomes:
measure: Improvement in symptoms
timeFrame: after 12 months of treatment
measure: Change in left ventricular ejection fraction
timeFrame: after 12 months of treatment
measure: Change in left ventricular end-diastolic diameter
timeFrame: after 12 months of treatment
measure: NT-proBNP level
timeFrame: after 12 months of treatment
measure: Incidence rate of drug adverse reactions
timeFrame: after 12 months of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shoujun Li, MD
role: STUDY_CHAIR
References: