- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06039540
Study of Drug Therapy for Pediatric Heart Failure
September 9, 2023 updated by: Shoujun Li, China National Center for Cardiovascular Diseases
A Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for Pediatric Heart Failure
The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients.
The main questions it aims to answer are:
- Can a modified drug therapy improve left ventricular function in pediatric heart failure patients?
- 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
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
paitent younger than 14 years of age with heart failure after suergry congenital heart disease
Description
Inclusion Criteria:
- Patients younger than 14 years of age
- heart failure after congenital heart surgery
- Ross > 2 or NYHA > 2
- LVEF<55%, or LVFS<25%
Exclusion Criteria:
- single ventricle
- congenital heart disease without anatomical correction
- 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
- Refuse to sign the informed consent or refuse to participate in this experiment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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).e
Traditional Drug Therapy Group
|
0.3mg/kg, tid
0.2mg/kg, bid
2-4mg/kg, bid
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 heart failure
Time Frame: after 6 months of treatment
|
During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function.
If LVEF falls under 55%, it is recorded as a recurrence.
|
after 6 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NT-proBNP level
Time Frame: after 6 months of treatment
|
The trend in NT-proBNP levels.
|
after 6 months of treatment
|
Incidence rate of drug adverse reactions
Time Frame: after 6 months of treatment
|
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
|
after 6 months of treatment
|
Readmission rate for heart failure
Time Frame: after 6 months of treatment
|
During follow-up visits, readmission for heart failure will be recorded.
|
after 6 months of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Shoujun Li, MD, Fuwai Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
June 22, 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
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Failure
- 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
- 2022-1-4032-1
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
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.
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