Pulmonary HypertensionPhase 2/3NCT01310751
Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery
A Phase 2/3 study testing iloprost nebuliser solusion and distilled water in people with Pulmonary Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD Read more about this study
- Who is it for?
- Ages 9 days to 12 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- iloprost nebuliser solusion and distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 2/3
- 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 9 days to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Before corrective procedure for CHD, two of bellow ten criteria should be met
- Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)
- EKG: right ventricular hypertrophy, right atrial dilatation
- Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
- Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
- Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels
Show all 10Show fewer
- Pp/Ps greater than 0.75
- Qp/Qs smaller than 1.5
- PVR grater than 9 Wood Unit/m2
- Rp/Rs graeter than 0.5
Who cannot join
- After corrective procedure for CHD:
- Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
- Severe arrhythmia led to low cardiac output
- PLT smaller than 50,000*109/L and obvious bleeding
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Shanghai, 200127
About this study
Official title: Randomized Double-blind Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension (PH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Disease (CHD)
The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD
Read the detailed description
Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.
Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.
- Conditions
- Pulmonary Hypertension
- Being tested
- iloprost nebuliser solusion, distilled water
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloprost nebuliser solusionDrug
Also called Venatvis
50 ng/kg/min inhalation for 10 minutes, q2h for 2 days
distilled waterDrug
Also called placebo
2 ml per session
| Study group | Role | What they receive |
|---|---|---|
| iloprost nebuliser solusion | Experimental | 50 ng/kg/min Receives: Drug: iloprost nebuliser solusion |
| distilled water | Placebo comparator | 2ml 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 (incidence rate of any events) consisting of reactive PH, PHC and death requiring additional pharmacological or other support administered within the first 48 hours after receiving study drug.
Reactive PH is defined as Pp/Ps greater than 0.5 for more than 30min.
End point of observation: in case of Pp/Ps greater than 0.5 for more than 30min or Pp/Ps greater than 1 for any time period, drug inhalation will be immediately stopped and other therapies such as NO inhalation and/or iloprost 80 ng/kg/min inhalation will be resorted to treat pulmonary hypertension.
Measured: The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later.
Secondary outcomes (1)
Change from base line of pulmonary heamodynamic measurements: Pp/Ps, PVRI, SVRI
Measured: The heamodynamic variable is measured before, after iloprost inhalation instantly and 30-min later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- Xu Zhuo-ming, M.D., PhD., Study director, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310751
- Sponsor's protocol ID
- SJTUMS-200903
- Status last verified
- Nov 2015
- First submitted
- 7 Mar 2011
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension (PH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Disease (CHD)
- ClinicalTrials.gov ID
- NCT01310751
- Acronym / sponsor ID
- SJTUMS-200903
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Mar 2011 (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 whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD
Detailed description
Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.
Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iloprost nebuliser solusion | Experimental | Drug: iloprost nebuliser solusion50 ng/kg/min |
| distilled water | Placebo comparator | Drug: distilled water2ml |
Who may qualify
- Ages
- 9 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Before corrective procedure for CHD, two of bellow ten criteria should be met
- Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)
- EKG: right ventricular hypertrophy, right atrial dilatation
- Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
- Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
Key exclusion criteria (4 listed)
- Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
- Severe arrhythmia led to low cardiac output
- PLT 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 |
|---|---|---|
| iloprost nebuliser solusionAlso: Venatvis50 ng/kg/min inhalation for 10 minutes, q2h for 2 days | Drug | iloprost nebuliser solusion |
| distilled waterAlso: placebo2 ml per session | Drug | distilled water |
Primary outcome
The primary end point is a composite variable (incidence rate of any events) consisting of reactive PH, PHC and death requiring additional pharmacological or other support administered within the first 48 hours after receiving study drug.
Time frame: The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later.
Reactive PH is defined as Pp/Ps greater than 0.5 for more than 30min. End point of observation: in case of Pp/Ps greater than 0.5 for more than 30min or Pp/Ps greater than 1 for any time period, drug inhalation will be immediately stopped and other therapies such as NO inhalation and/or iloprost 80 ng/kg/min inhalation will be resorted to treat pulmonary hypertension.
1 secondary outcome
Change from base line of pulmonary heamodynamic measurements: Pp/Ps, PVRI, SVRI
Time frame: The heamodynamic variable is measured before, after iloprost inhalation instantly and 30-min later.
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 24 Nov 2015.
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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.
Xu Zhuo-ming, M.D., PhD. study director
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,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 Phase 2/3 study testing iloprost nebuliser solusion and distilled water in people with Pulmonary Hypertension, 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 10 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 24 Nov 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (incidence rate of any events) consisting of reactive PH, PHC and death requiring additional pharmacological or other support administered within the first 48 hours after receiving study drug. (time frame: The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later.). 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 24 Nov 2015.