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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Mitral Insufficiency
• Intervention / Treatment: Drug: Captopril Tablets; Drug: Metoprolol Oral Tablet; Drug: Spironolactone Tablets; Drug: Torsemide Tablets; Drug: Potassium citrate powder

• Study Type: Observational
• Enrollment (Estimated): 164

Contacts and Locations

• Study Contact: Name: Kai Ma, PhD; Phone Number: +86 15901428497; Email: drmakaifw@yahoo.com
• Study Contact Backup: Name: Zheng Dou, PhD; Phone Number: +86 18810673618; Email: drdouzheng@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital
      • Contact: Shoujun Li, MD; Phone Number: +86 13501071589; Email: drlishoujunfw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children under the age of 14 after mitral valve repair surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the recurrence rate of moderate to severe mitral valve regurgitation	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.	after 12 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in symptoms	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.	after 12 months of treatment
Improvement in left ventricular function	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.	after 12 months of treatment
NT-proBNP level	The trend in NT-proBNP levels.	after 12 months of treatment
Incidence rate of drug adverse reactions	The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.	after 12 months of treatment

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Shanghai Children's Medical Center; Chinese Academy of Medical Sciences, Fuwai Hospital; Guangzhou Women and Children's Medical Center; Children's Hospital of Chongqing Medical University; Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
• Investigators: Study Chair: Shoujun Li, MD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 9, 2023
• First Submitted That Met QC Criteria: September 9, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: mitral regurgitation; congenital heart disease; drug therapy; mitral valve repair postoperative
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Respiratory System Agents; Hormone Antagonists; Angiotensin-Converting Enzyme Inhibitors; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Expectorants; Sodium Potassium Chloride Symporter Inhibitors; Spironolactone; Metoprolol; Captopril; Potassium Citrate; Torsemide
• Other Study ID Numbers: 2022-GSP-GG-19-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No