Congenital Mitral InsufficiencyNCT06039592
Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair
An observational study of Congenital Mitral Insufficiency, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Congenital Mitral Insufficiency
- What is being tested?
- Captopril Tablets, Metoprolol Oral Tablet and Spironolactone Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under the age of 14 after mitral valve repair surgery.
Who may be able to join
- under 14 years old
- after mitral valve repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Shoujun Li, MD, +86 13501071589, drlishoujunfw@163.com
About this study
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
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.
- Conditions
- Congenital Mitral Insufficiency
- Being tested
- Captopril Tablets, Metoprolol Oral Tablet, Spironolactone Tablets, Torsemide Tablets, Potassium citrate powder
- Keywords
- congenital heart disease, mitral regurgitation, mitral valve repair postoperative, drug therapy
- Medical subject headings
- Heart Defects, Congenital, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril TabletsDrug
0.3mg/kg, tid
Metoprolol Oral TabletDrug
0.2mg/kg, bid
Spironolactone TabletsDrug
2-4mg/kg, bid
Torsemide TabletsDrug
0.2-0.5mg/mg, bid
Potassium citrate powderDrug
0.06g/kg, tid
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Captopril Tablets; Drug: Metoprolol Oral Tablet; Drug: Spironolactone Tablets; Drug: Torsemide Tablets; Drug: Potassium citrate powder | |
| 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). Receives: Drug: Torsemide Tablets; Drug: Potassium citrate powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 12 months of treatment
Secondary outcomes (4)
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.
Measured: 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.
Measured: after 12 months of treatment
NT-proBNP level
The trend in NT-proBNP levels.
Measured: 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.
Measured: after 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Apr 2022
- Primary completion15 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Mitral InsufficiencyStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Shoujun Li, China National Center for Cardiovascular Diseases
- Investigators
- Shoujun Li, MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039592
- Sponsor's protocol ID
- 2022-GSP-GG-19-3
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039592
- Acronym / sponsor ID
- 2022-GSP-GG-19-3
- Conditions
- Congenital Mitral Insufficiency
- Keywords
- congenital heart disease, mitral regurgitation, mitral valve repair postoperative, drug therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- 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
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Drug Therapy Group | – | Drug: Captopril Tablets, Drug: Metoprolol Oral Tablet, Drug: Spironolactone Tablets, Drug: Torsemide Tablets, Drug: Potassium citrate powderPatient 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). |
| Traditional Drug Therapy Group | – | Drug: Torsemide Tablets, Drug: Potassium citrate powderPatient 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). |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under the age of 14 after mitral valve repair surgery.
Key inclusion criteria (2 listed)
- under 14 years old
- after mitral valve repair
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Captopril Tablets0.3mg/kg, tid | Drug | Modified Drug Therapy Group |
| Metoprolol Oral Tablet0.2mg/kg, bid | Drug | Modified Drug Therapy Group |
| Spironolactone Tablets2-4mg/kg, bid | Drug | Modified Drug Therapy Group |
| Torsemide Tablets0.2-0.5mg/mg, bid | Drug | Modified Drug Therapy Group, Traditional Drug Therapy Group |
| Potassium citrate powder0.06g/kg, tid | Drug | Modified Drug Therapy Group, Traditional Drug Therapy Group |
Primary outcome
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.
4 secondary outcomes
Improvement in symptoms
Time frame: after 12 months of treatment
Improvement in left ventricular function
Time frame: after 12 months of treatment
NT-proBNP level
Time frame: after 12 months of treatment
Incidence rate of drug adverse reactions
Time frame: after 12 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoujun Li, MD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Mitral Insufficiency, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Ma, PhD (+86 15901428497, drmakaifw@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recurrence rate of moderate to severe mitral valve regurgitation (time frame: after 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.