Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT06039592

Collaborator

Shanghai Children's Medical Center (Other), Chinese Academy of Medical Sciences, Fuwai Hospital (Other), Guangzhou Women and Children's Medical Center (Other), Children's Hospital of Chongqing Medical University (Other), Fuwai Central China Cardiovascular Hospital, Zhengzhou, China (Other)

164

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Mitral Insufficiency	Drug: Captopril Tablets Drug: Metoprolol Oral Tablet Drug: Spironolactone Tablets Drug: Torsemide Tablets Drug: Potassium citrate powder

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

164 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Oct 15, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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).	Drug: Captopril Tablets 0.3mg/kg, tid Drug: Metoprolol Oral Tablet 0.2mg/kg, bid Drug: Spironolactone Tablets 2-4mg/kg, bid Drug: Torsemide Tablets 0.2-0.5mg/mg, bid Drug: 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).	Drug: Torsemide Tablets 0.2-0.5mg/mg, bid Drug: Potassium citrate powder 0.06g/kg, tid

Arm

Intervention/Treatment

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).

Drug: Captopril Tablets

0.3mg/kg, tid

Drug: Metoprolol Oral Tablet

0.2mg/kg, bid

Drug: Spironolactone Tablets

2-4mg/kg, bid

Drug: Torsemide Tablets

0.2-0.5mg/mg, bid

Drug: 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).

Drug: Torsemide Tablets

0.2-0.5mg/mg, bid

Drug: Potassium citrate powder

0.06g/kg, tid

Outcome Measures

Primary Outcome Measures

the recurrence rate of moderate to severe mitral valve regurgitation [after 12 months of treatment]
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.

Secondary Outcome Measures

Improvement in symptoms [after 12 months of treatment]
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.
Improvement in left ventricular function [after 12 months of treatment]
Based on the echocardiogram, measurements are taken for left ventricular ejection fraction, left ventricular fractional shortening, left ventricular end-diastolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic diameter, and left ventricular end-systolic volume.
NT-proBNP level [after 12 months of treatment]
The trend in NT-proBNP levels.
Incidence rate of drug adverse reactions [after 12 months of treatment]
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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