Heart Failure CongenitalNCT06039540
Study of Drug Therapy for Pediatric Heart Failure
An observational study of Heart Failure Congenital, 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 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… Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Heart Failure Congenital
- What is being tested?
- Captopril Tablets, Metoprolol Oral Tablet and Spironolactone Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 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
- Child
Study population: paitent younger than 14 years of age with heart failure after suergry congenital heart disease
Who may be able to join
- Patients younger than 14 years of age
- heart failure after congenital heart surgery
- Ross > 2 or NYHA > 2
- LVEF<55%, or LVFS<25%
Who cannot join
- 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
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 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.
- Conditions
- Heart Failure Congenital
- Being tested
- Captopril Tablets, Metoprolol Oral Tablet, Spironolactone Tablets, Torsemide Tablets, Potassium citrate powder
- Keywords
- congenital heart failure, drug therapy, congenital heart disease postoperative
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).e Traditional Drug Therapy Group 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 heart failure
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.
Measured: after 6 months of treatment
Secondary outcomes (3)
NT-proBNP level
The trend in NT-proBNP levels.
Measured: after 6 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 6 months of treatment
Readmission rate for heart failure
During follow-up visits, readmission for heart failure will be recorded.
Measured: after 6 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 Jan 2022
- Primary completion22 Jun 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 Heart Failure CongenitalStudies 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
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Peking University First Hospital, Beijing Children's Hospital
- 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
- NCT06039540
- Sponsor's protocol ID
- 2022-1-4032-1
- 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 Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for Pediatric Heart Failure
- ClinicalTrials.gov ID
- NCT06039540
- Acronym / sponsor ID
- 2022-1-4032-1
- Conditions
- Heart Failure Congenital
- Keywords
- congenital heart failure, drug therapy, congenital heart disease postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Peking University First Hospital, Beijing Children's Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 22 Jun 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 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 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).e Traditional Drug Therapy Group |
| 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
- Age groups
- Child
- Study population
- paitent younger than 14 years of age with heart failure after suergry congenital heart disease
Key inclusion criteria (4 listed)
- Patients younger than 14 years of age
- heart failure after congenital heart surgery
- Ross > 2 or NYHA > 2
- LVEF<55%, or LVFS<25%
Key exclusion criteria (8 listed)
- 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
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 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.
3 secondary outcomes
NT-proBNP level
Time frame: after 6 months of treatment
Incidence rate of drug adverse reactions
Time frame: after 6 months of treatment
Readmission rate for heart failure
Time frame: after 6 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
Related trials for Heart Failure Congenital
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Heart Failure, Left Ventricular Dysfunction
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
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 Heart Failure Congenital, 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 4 inclusion and 8 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 heart failure (time frame: after 6 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.