- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037434
Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
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
-
-
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
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
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).
|
0.3mg/kg, tid
0.2mg/kg, bid
2-4mg/kg, bid
0.2-0.5mg/mg, bid
0.06g/kg, tid
|
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).
|
0.2-0.5mg/mg, bid
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
Time Frame: 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.
|
after 12 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in symptoms
Time Frame: 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.
|
after 12 months of treatment
|
NT-proBNP level
Time Frame: after 12 months of treatment
|
The trend in NT-proBNP levels.
|
after 12 months of treatment
|
Incidence rate of drug adverse reactions
Time Frame: after 12 months of treatment
|
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
|
after 12 months of treatment
|
Change in left ventricular ejection fraction
Time Frame: after 12 months of treatment
|
Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.
|
after 12 months of treatment
|
Change in left ventricular end-diastolic diameter
Time Frame: after 12 months of treatment
|
Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.
|
after 12 months of treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Shoujun Li, MD, Fuwai Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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-19-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Mitral Insufficiency
-
China National Center for Cardiovascular DiseasesShanghai Children's Medical Center; Chinese Academy of Medical Sciences, Fuwai... and other collaboratorsRecruitingCongenital Mitral InsufficiencyChina
-
China National Center for Cardiovascular DiseasesShanghai Children's Medical Center; Chinese Academy of Medical Sciences, Fuwai... and other collaboratorsRecruiting
-
Closed Joint-Stock Company NeoCorResearch Institute for Complex Problems of Cardiovascular Diseases, Russia; CT Medical Limited Liability CompanyRecruitingDiseases of Mitral and Aortic Valves | Valvular Heart Disease (Aortic and Mitral Valves) | Rheumatic Disorders of Mitral and Aortic Valves | Other Congenital Malformations of Aortic and Mitral Valves | Mitral Valve Insufficiency and Aortic Valve InsufficiencyRussian Federation
-
Abbott Medical DevicesCompletedMitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Functional Mitral Regurgitation | Mitral Stenosis With InsufficiencyJapan
-
Edwards LifesciencesActive, not recruitingMitral Regurgitation | Mitral Insufficiency | Mitral Repair | Mitral Valve | Annuloplasty | Edwards CardiobandSwitzerland, Germany, Italy
-
Edwards LifesciencesRecruitingMitral Regurgitation | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada, Switzerland, Germany
-
Universitätsklinikum Hamburg-EppendorfUniversity Hospital, Bordeaux; Montreal Heart InstituteRecruitingMitral RegurgitationSwitzerland, United States, Denmark, United Kingdom, France, Canada, Germany, Australia, Italy, Norway
-
Medtentia International Ltd OyCompletedMitral Regurgitation | Mitral InsufficiencyFinland
-
4C Medical Technologies, Inc.RecruitingMitral Regurgitation | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Mitral IncompetenceUnited States
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
Clinical Trials on Captopril Tablets
-
University of CalgaryDr. Sandra DumanskiRecruitingHormone TherapyCanada
-
Cairo UniversityUnknownMetabolic Syndrome | Kidney Insufficiency | Diabete Type 2Egypt
-
Rigshospitalet, DenmarkUnknown
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyTerminatedLung Cancer | Pulmonary Complications | Radiation FibrosisUnited States
-
National Taiwan University HospitalNovartisUnknown
-
Chongqing Medical UniversityChinese PLA General Hospital; Tianjin Medical University General Hospital; Chinese...Recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompleted
-
Assistance Publique - Hôpitaux de ParisUnknownCOVID-19 | Coronavirus Infection | PneumoniaFrance
-
Wuhan UniversityRecruitingRadiotherapy Side Effect | Taking CaptoprilChina
-
Natural Wellness EgyptNot yet recruitingEssential Hypertension