Pulmonary HypertensionPhase 2NCT01320878
Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
A Phase 2 study testing iloprost nebuliser solution 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 objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects. Read more about this study
- Who is it for?
- Ages 4 to 12 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
- 64 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 2
- 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 4 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:
- Decreased respiratory infection \& decreased exercise tolerance
- Pulse SaO2 < 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 vessel 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
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- Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels
- Pp/Ps > 0.75
- Qp/Qs <1.5
- PVR > 9WU/m2
- Rp/Rs > 0.5
Who cannot join
- a body weight of < 2 kg,
- prematurity (birth 36 weeks postconceptual age)
- renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)
- PLT < 50,000*109/L and obvious bleeding
- LCOS or hypotension on arrival to the intensive care unit
- After corrective procedure for CHD:
- deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
- severe arrhythmia led to low cardiac output
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: A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.
Read the detailed description
Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.
- Conditions
- Pulmonary Hypertension
- Being tested
- iloprost nebuliser solution, distilled water
- Keywords
- pulmonary hypertension
- 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 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
iloprost nebuliser solutionDrug
Also called Ventavis
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
distilled waterDrug
Also called Treeful
distilled water 2 ml per session
| Study group | Role | What they receive |
|---|---|---|
| iloprost low dose group | Active comparator | iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days Receives: Drug: iloprost nebuliser solution |
| iloprost high dose group | Active comparator | iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days Receives: Drug: iloprost nebuliser solution |
| placebo group | Placebo comparator | distilled water 2 ml per session Receives: Drug: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause pulmonary artery pressure
Measured: one year
Secondary outcomes (5)
central venous pressure
Measured: one year
blood pressure
Measured: one year
cardiac index
Measured: one year
pulmonary vascular resistance
Measured: one year
mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionDec 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 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
- Zhuo-ming Xu, MD,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
- NCT01320878
- Sponsor's protocol ID
- SJTUMS-10-16
- Status last verified
- Jun 2012
- First submitted
- 22 Mar 2011
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gorenflo M, Gu H, Xu Z. Peri-operative pulmonary hypertension in paediatric patients: current strategies in children with congenital heart disease. Cardiology. 2010;116(1):10-7. doi: 10.1159/000313864. Epub 2010 Apr 24.
PubMed 20424447
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01320878
- Acronym / sponsor ID
- SJTUMS-10-16
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 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 objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.
Detailed description
Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iloprost low dose group | Active comparator | Drug: iloprost nebuliser solutioniloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days |
| iloprost high dose group | Active comparator | Drug: iloprost nebuliser solutioniloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days |
| placebo group | Placebo comparator | Drug: distilled waterdistilled water 2 ml per session |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Decreased respiratory infection \& decreased exercise tolerance
- Pulse SaO2 < 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 vessel 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 (8 listed)
- a body weight of < 2 kg,
- prematurity (birth 36 weeks postconceptual age)
- renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)
- PLT < 50,000*109/L and obvious bleeding
- LCOS or hypotension on arrival to the intensive care unit
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 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days | Drug | iloprost low dose group |
| iloprost nebuliser solutionAlso: Ventavisiloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days | Drug | iloprost high dose group |
| distilled waterAlso: Treefuldistilled water 2 ml per session | Drug | placebo group |
Primary outcome
all cause pulmonary artery pressure
Time frame: one year
5 secondary outcomes
central venous pressure
Time frame: one year
blood pressure
Time frame: one year
cardiac index
Time frame: one year
pulmonary vascular resistance
Time frame: one year
mortality
Time frame: one year
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 18 Jun 2012.
- Results publication: PubMed 20424447Gorenflo M, Gu H, Xu Z. Peri-operative pulmonary hypertension in paediatric patients: current strategies in children with congenital heart disease. Cardiology. 2010;116(1):10-7. doi: 10.1159/000313864. Epub 2010 Apr 24.
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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.
Zhuo-ming Xu, MD,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 study testing iloprost nebuliser solution 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 11 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: finished, as of the sponsor's last update on 18 Jun 2012. 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 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.
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?
all cause pulmonary artery pressure (time frame: one year). 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 NCT01320878, 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 18 Jun 2012.