Clinical trial NCT06039592: Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair
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 in Improving Left Ventricular Function After Mitral Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Mitral Insufficiency
Keywords: congenital heart disease
mitral regurgitation
mitral valve repair postoperative
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: 2023-09-15
Enrollment: 164
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 after mitral valve repair 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 after mitral repair.

The main questions it aims to answer are:

* Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients after mitral repair?
* 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.


Eligibility criteria: Inclusion Criteria:

* under 14 years old
* after mitral valve repair

Exclusion Criteria:

* 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

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: Improvement in left ventricular function
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: