Pulmonary HypertensionPhase 3NCT02865733
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
A Phase 3 study testing Remodulin and distilled water in people with Pulmonary Hypertension, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Remodulin and distilled water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 20 Aug 2019
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- After Fontan procedure, the criteria should be met
- mPAP greater than 15 mmHg
- TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)
Who cannot join
- After Fontan surgery :
- Severe arrhythmia led to low cardiac output
- Platelets smaller than 50,000*109/L and obvious bleeding
About this study
Official title: Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation
The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.
Read the detailed description
PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.
- Conditions
- Pulmonary Hypertension
- Being tested
- Remodulin, distilled water
- Keywords
- Remodulin®, pulmonary vascular resistance, univentricular physiology
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemodulinDrug
Also called Treprostinil Injection
After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min.
distilled waterDrug
Also called placebo
After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr.
| Study group | Role | What they receive |
|---|---|---|
| Remodulin Injection | Experimental | Drug: Remodulin Injection Dosage:5 ng/kg/min-80ng/kg/min(0.15ml/hr-2.4ml/hr) Frequency: intravenous maintenance increase at a rate of 10ng/kg/min (0.3ml/hr)every 30 minutes Durations:48 hours Receives: Drug: Remodulin |
| Distilled water group | Placebo comparator | Drug:distilled water Dosage:0.15ml/hr-2.4ml/hr Frequency:increase at a rate of 0.3ml/hr every 30 minutes Durations:48 hours Receives: Drug: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is a composite variable
consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance
Measured: the first 48 hours after Remodulin used
Secondary outcomes (1)
Change from base line of pulmonary hemodynamic measurements
Pp/Ps reduce >10% or TPG≤6mmHg.
Measured: baseline and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Dec 2018
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 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, M.D.,Ph,D., Study director, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865733
- Sponsor's protocol ID
- SJTUMS-201607
- Status last verified
- Oct 2020
- First submitted
- 1 Aug 2016
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen X, Cai XM, Zhang MJ, Xu JH, Li H, Xu ZM. Pharmacokinetics of treprostinil in children with functional single-ventricle pulmonary arterial hypertension: a randomized controlled trial. Ann Transl Med. 2021 Jul;9(14):1163. doi: 10.21037/atm-21-3188.
PubMed 34430604
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
- Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation
- ClinicalTrials.gov ID
- NCT02865733
- Acronym / sponsor ID
- SJTUMS-201607
- Conditions
- Pulmonary Hypertension
- Keywords
- Remodulin®, pulmonary vascular resistance, univentricular physiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 12 Aug 2016 (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 aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.
Detailed description
PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remodulin Injection | Experimental | Drug: RemodulinDrug: Remodulin Injection Dosage:5 ng/kg/min-80ng/kg/min(0.15ml/hr-2.4ml/hr) Frequency: intravenous maintenance increase at a rate of 10ng/kg/min (0.3ml/hr)every 30 minutes Durations:48 hours |
| Distilled water group | Placebo comparator | Drug: distilled waterDrug:distilled water Dosage:0.15ml/hr-2.4ml/hr Frequency:increase at a rate of 0.3ml/hr every 30 minutes Durations:48 hours |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- After Fontan procedure, the criteria should be met
- mPAP greater than 15 mmHg
- TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)
Key exclusion criteria (3 listed)
- Severe arrhythmia led to low cardiac output
- Platelets smaller than 50,000*109/L and obvious bleeding
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 |
|---|---|---|
| RemodulinAlso: Treprostinil InjectionAfter Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min. | Drug | Remodulin Injection |
| distilled waterAlso: placeboAfter Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr. | Drug | Distilled water group |
Primary outcome
The primary end point is a composite variable
Time frame: the first 48 hours after Remodulin used
consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance
1 secondary outcome
Change from base line of pulmonary hemodynamic measurements
Time frame: baseline and 48 hours
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.
- Derived from this study: PubMed 34430604Chen X, Cai XM, Zhang MJ, Xu JH, Li H, Xu ZM. Pharmacokinetics of treprostinil in children with functional single-ventricle pulmonary arterial hypertension: a randomized controlled trial. Ann Transl Med. 2021 Jul;9(14):1163. doi: 10.21037/atm-21-3188.
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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, M.D.,Ph,D. study director
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remodulin and distilled water in people with Pulmonary Hypertension, run by Shanghai Jiao Tong University School of Medicine.
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 3 inclusion and 3 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.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary end point is a composite variable (time frame: the first 48 hours after Remodulin used). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865733, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 7 Nov 2026.