Pulmonary HypertensionPhase 3NCT01598441
Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)
A Phase 3 study testing iloprost nebuliser solution and distilled water in people with Pulmonary Hypertension, run by Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of… Read more about this study
- Who is it for?
- Ages 7 days to 18 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- iloprost nebuliser solution and distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2012to Nov 2016
- 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 7 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CHD children who have associated PH risk factors and have accepted biventricular repair
- Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)
Who cannot join
- severe mitral stenosis
- obstructive drainage of pulmonary veins
- platelet count < 50,000,000,000/L \& obvious bleeding
Trial locations and contacts
3 sites in 1 country.
China3 sites
Guangzhou Children's Hospital
Guangzhou, Guangdong, 510000
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Shanghai, 200127
Wuhan Asia Hear Hospital
Wuhan, Hubei, 430022
About this study
Official title: Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)
This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.
Read the detailed description
Primary objectives:
- To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
- To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.
Secondary objectives:
- To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.
- To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.
- Conditions
- Pulmonary Hypertension
- Being tested
- iloprost nebuliser solution, distilled water
- Keywords
- pulmonary hypertension, pulmonary hypertensive crisis
- 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 solutionDrug
Also called Ventavis
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
distilled waterDrug
Also called Treeful
1-2 ml aerosolized distilled water inhalation per session
| Study group | Role | What they receive |
|---|---|---|
| iloprost | Experimental | Iloprost nebuliser solution 500 ng/kg inhaled Receives: Drug: iloprost nebuliser solution |
| distilled water | Placebo comparator | aerosolized distilled water 1-2 ml Receives: Drug: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total incidence of RPH, PHC or death
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur:
- RPH lasting for more than 30 mintues; or
- PHC at any time; or
- death
Measured: within 48 hours after surgery
Secondary outcomes (1)
Change from base line of pulmonary hemodynamic measurements
- Pp/Ps
- NYHA class function
- SvO2
- PAO2
Measured: within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2016
- Study completionNov 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
- Responsible party
- Principal investigator, Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhuomin Xu, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598441
- Sponsor's protocol ID
- SCMCIRB-201127
- Status last verified
- Jan 2016
- First submitted
- 6 May 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)
- ClinicalTrials.gov ID
- NCT01598441
- Acronym / sponsor ID
- SCMCIRB-201127
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, pulmonary hypertensive crisis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
- Study start
- Jun 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 May 2012 (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.
This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.
Detailed description
Primary objectives:
- To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
- To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.
Secondary objectives:
- To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.
- To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iloprost | Experimental | Drug: iloprost nebuliser solutionIloprost nebuliser solution 500 ng/kg inhaled |
| distilled water | Placebo comparator | Drug: distilled wateraerosolized distilled water 1-2 ml |
Who may qualify
- Ages
- 7 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- CHD children who have associated PH risk factors and have accepted biventricular repair
- Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)
Key exclusion criteria (3 listed)
- severe mitral stenosis
- obstructive drainage of pulmonary veins
- platelet count < 50,000,000,000/L \& 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 solutionAlso: VentavisIloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days | Drug | iloprost |
| distilled waterAlso: Treeful1-2 ml aerosolized distilled water inhalation per session | Drug | distilled water |
Primary outcome
The total incidence of RPH, PHC or death
Time frame: within 48 hours after surgery
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: * RPH lasting for more than 30 mintues; or * PHC at any time; or * death
1 secondary outcome
Change from base line of pulmonary hemodynamic measurements
Time frame: within 48 hours after surgery
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 22 Nov 2016.
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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.
Zhuomin Xu, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iloprost nebuliser solution and distilled water in people with Pulmonary Hypertension, run by Shanghai Jiao Tong University School of Medicine at 3 sites 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 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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 total incidence of RPH, PHC or death (time frame: within 48 hours after surgery). 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 22 Nov 2016.