Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

NCT06037434 | Unknown FDA Drug

• 1 other identifier: 2022-GSP-GG-19-1
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Mitral Insufficiency

Keywords

congenital heart disease; mitral regurgitation; drug therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Improvement in symptoms

  after 12 months of treatment

• Change in left ventricular ejection fraction

  after 12 months of treatment

• Change in left ventricular end-diastolic diameter

  after 12 months of treatment

• NT-proBNP level

  after 12 months of treatment

• Incidence rate of drug adverse reactions

  after 12 months of treatment

Study Arms (2)

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; Drug: Metoprolol Oral Tablet; Drug: Spironolactone Tablets; Drug: Torsemide Tablets; Drug: Potassium citrate powder

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).

Drug: Torsemide Tablets; Drug: Potassium citrate powder

Interventions

Captopril Tablets DRUG

0.3mg/kg, tid

Modified Drug Therapy Group

Metoprolol Oral Tablet DRUG

0.2mg/kg, bid

Modified Drug Therapy Group

Spironolactone Tablets DRUG

2-4mg/kg, bid

Modified Drug Therapy Group

Torsemide Tablets DRUG

0.2-0.5mg/mg, bid

Modified Drug Therapy Group; the Traditional Drug Therapy Group

Potassium citrate powder DRUG

0.06g/kg, tid

Modified Drug Therapy Group; the Traditional Drug Therapy Group

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Shanghai Children's Medical Center: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Mitral Valve Insufficiency

Interventions

Captopril; Metoprolol; Spironolactone; Torsemide

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shoujun Li, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Kai Ma, PhD

CONTACT

+86 15901428497; drmakaifw@yahoo.com

Zheng Dou, PhD

CONTACT

+86 18810673618; drdouzheng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Congenital Heart Surgery Center

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 14, 2023
• Study Start: April 1, 2022
• Primary Completion: August 9, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)