Congenital Heart DefectsNCT01941576
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
A study testing recombinant human brain natriuretic peptide (rhBNP) in people with Congenital Heart Defects and Tetralogy Of Fallot, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Congenital Heart Defects, Tetralogy Of Fallot
- What is being tested?
- recombinant human brain natriuretic peptide (rhBNP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2013to 20 Jul 2019
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent obtained from patient's legally acceptable representative.
- Pediatric patients after Repair of Tetralogy Of Fallot.
Who cannot join
- Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- Treatment or planned treatment with another investigational drug within 3 months of screening.
- Known hypersensitivity to bosentan or any of the excipients
- cardiogenic shock and inclination of hypotension（SBP< 60mmHg）.
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
About this study
The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.
Read the detailed description
CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.
- Conditions
- Congenital Heart Defects, Tetralogy Of Fallot
- Being tested
- recombinant human brain natriuretic peptide (rhBNP), Placebo (0.9% sodium chloride)
- Keywords
- Heart defects, Congenital, rhBNP, heart failure
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human brain natriuretic peptide (rhBNP)Drug
Patients are first given a loading dose of recombinant human brain natriuretic peptide (rhBNP) 1.5 mcg/kg, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours.
Placebo (0.9% sodium chloride)Drug
Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation.
| Study group | Role | What they receive |
|---|---|---|
| rhBNP Group | Experimental | Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a rhBNP infusion 24 hours after operation. The dose of recombinant human brain natriuretic peptide (rhBNP) will be 1.5 mcg/kg for loading, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours. Receives: Drug: recombinant human brain natriuretic peptide (rhBNP) |
| Placebo Group | Placebo comparator | Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation. Receives: Drug: Placebo (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in BNP and CVP after the infusion of rhBNP
we will evaluate the cardiac function through the consecutive changed numerical value of brain natriuretic peptide and Central Venous Pressure.
Measured: 12 months after operation of Tetralogy Of Fallot
Secondary outcomes (1)
Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen
we evaluate the renal function through the volume of urine out and numerical value of serum creatinine and blood urea nitrogen.
Measured: 12 months after operation of Tetralogy Of Fallot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start1 Sep 2013
- Primary completion31 Dec 2017
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhuoming Xu, MD,PhD, Study director, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941576
- Sponsor's protocol ID
- SJTUMS-20130903
- Status last verified
- Oct 2020
- First submitted
- 3 Sep 2013
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
- ClinicalTrials.gov ID
- NCT01941576
- Acronym / sponsor ID
- SJTUMS-20130903
- Conditions
- Congenital Heart Defects, Tetralogy Of Fallot
- Keywords
- Heart defects, Congenital, rhBNP, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 13 Sep 2013 (estimated)
- 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 purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.
Detailed description
CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBNP Group | Experimental | Drug: recombinant human brain natriuretic peptide (rhBNP)Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a rhBNP infusion 24 hours after operation. The dose of recombinant human brain natriuretic peptide (rhBNP) will be 1.5 mcg/kg for loading, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours. |
| Placebo Group | Placebo comparator | Drug: Placebo (0.9% sodium chloride)Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Signed informed consent obtained from patient's legally acceptable representative.
- Pediatric patients after Repair of Tetralogy Of Fallot.
Key exclusion criteria (4 listed)
- Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- Treatment or planned treatment with another investigational drug within 3 months of screening.
- Known hypersensitivity to bosentan or any of the excipients
- cardiogenic shock and inclination of hypotension（SBP< 60mmHg）.
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 |
|---|---|---|
| recombinant human brain natriuretic peptide (rhBNP)Patients are first given a loading dose of recombinant human brain natriuretic peptide (rhBNP) 1.5 mcg/kg, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours. | Drug | rhBNP Group |
| Placebo (0.9% sodium chloride)Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation. | Drug | Placebo Group |
Primary outcome
Changes from Baseline in BNP and CVP after the infusion of rhBNP
Time frame: 12 months after operation of Tetralogy Of Fallot
we will evaluate the cardiac function through the consecutive changed numerical value of brain natriuretic peptide and Central Venous Pressure.
1 secondary outcome
Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen
Time frame: 12 months after operation of Tetralogy Of Fallot
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
Zhuoming Xu, MD,PhD study director
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant human brain natriuretic peptide (rhBNP) in people with Congenital Heart Defects and Tetralogy Of Fallot, run by Shanghai Jiao Tong University School of Medicine 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 4 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: finished, as of the sponsor's last update on 28 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in BNP and CVP after the infusion of rhBNP (time frame: 12 months after operation of Tetralogy Of Fallot). 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 28 Oct 2020.