Congenital Heart DiseasePhase 1AlprostadilNCT04054115
Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow
A Phase 1 study testing Alprostadil 5 MCG Injection in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The second stage operation towards single ventricle palliation is 'bidirectional cavopulmonary connection' (BCPC). The superior vena cava is connected to the pulmonary artery, diverting 'blue' blood from the upper body (including the brain) to the lungs. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Alprostadil 5 MCG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2019to 9 Nov 2022
- Phase
- Phase 1
- 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 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Patients who are hypersensitive to this product or to any ingredient in its formulation.
- Patients with seizure disorders or coagulopathies.
- Patients with abnormal kidney function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection
The second stage operation towards single ventricle palliation is 'bidirectional cavopulmonary connection' (BCPC). The superior vena cava is connected to the pulmonary artery, diverting 'blue' blood from the upper body (including the brain) to the lungs. A successful BCPC requires sufficient and easy blood flow through the lungs. Alprostadil is the synthetic form of prostaglandin (hormone that causes dilation of blood vessels) and has been shown to increase blood flow in the brain hence increasing blood flow to the lungs after BCPC, potentially useful in managing children post BCPC with low flow to the lungs and thus poor oxygenation. This study propose to investigate acute effects of Alprostadil on different blood vessels after BCPC.
- Conditions
- Congenital Heart Disease
- Being tested
- Alprostadil 5 MCG Injection
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprostadil 5 MCG InjectionDrug
During the MRI, Alprostadil infusion will be started and titrated to the target dose, ensuring there is a less than 20% drop in blood pressure from baseline. Repeat pressure and MRI flow measurements once Alprostadil reaches 0.1mcg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 1. Baseline cardiac catheterization under GA. (Standard of Care, SOC)
2. Transfer patient to MRI unit
3. Baseline MRI
1. Obtain ABG for pCO2 from existing femoral arterial access.
2. Repeat pressure measurements with existing catheters at the SVC, RA and Aorta.
3. MRI phase contrast imaging for flow measurements(SOC).
4. During the MRI, Alprostadil infusion will be started and titrated to the target dose 0.1mcg/kg/min, provided there is a less than 20% drop in blood pressure from baseline.
5. Post alprostadil infusion
1. 1ml blood sample taken from existing femoral venous access for prostaglandin level.
2. Repeat pressure measurements with existing catheters left at the SVC, RA and Aorta.
3. Repeat MRI flow measurements
7.Return to cath lab if further intervention required. 8.Recovery and monitoring for 4 to 6 hours prior to discharge(SOC). Receives: Drug: Alprostadil 5 MCG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Cerebral blood flow
Measured: will be measured 30 minutes to 40 minutes after infusion of alprostadil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start23 Jul 2019
- Primary completion24 Feb 2021
- Study completion9 Nov 2022
Why it stopped: Covid 19 and difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with a bidirectional Glenn in their Pre-Fontan evaluation.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Chaturvedi, The Hospital for Sick Children
- Investigators
- Rajiv Chaturvedi, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054115
- Sponsor's protocol ID
- 1000060394
- Acronym
- Alprostadil
- Status last verified
- Feb 2023
- First submitted
- 9 Aug 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection
- ClinicalTrials.gov ID
- NCT04054115
- Acronym / sponsor ID
- Alprostadil / 1000060394
- Conditions
- Congenital Heart Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid 19 and difficulty with recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 13 Aug 2019 (actual)
- 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 second stage operation towards single ventricle palliation is 'bidirectional cavopulmonary connection' (BCPC). The superior vena cava is connected to the pulmonary artery, diverting 'blue' blood from the upper body (including the brain) to the lungs. A successful BCPC requires sufficient and easy blood flow through the lungs. Alprostadil is the synthetic form of prostaglandin (hormone that causes dilation of blood vessels) and has been shown to increase blood flow in the brain hence increasing blood flow to the lungs after BCPC, potentially useful in managing children post BCPC with low flow to the lungs and thus poor oxygenation. This study propose to investigate acute effects of Alprostadil on different blood vessels after BCPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with a bidirectional Glenn in their Pre-Fontan evaluation.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Alprostadil 5 MCG Injection1. Baseline cardiac catheterization under GA. (Standard of Care, SOC) 2. Transfer patient to MRI unit 3. Baseline MRI 1. Obtain ABG for pCO2 from existing femoral arterial access. 2. Repeat pressure measurements with existing catheters at the SVC, RA and Aorta. 3. MRI phase contrast imaging for flow measurements(SOC). 4. During the MRI, Alprostadil infusion will be started and titrated to the target dose 0.1mcg/kg/min, provided there is a less than 20% drop in blood pressure from baseline. 5. Post alprostadil infusion 1. 1ml blood sample taken from existing femoral venous access for prostaglandin level. 2. Repeat pressure measurements with existing catheters left at the SVC, RA and Aorta. 3. Repeat MRI flow measurements 7.Return to cath lab if further intervention required. 8.Recovery and monitoring for 4 to 6 hours prior to discharge(SOC). |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients who are hypersensitive to this product or to any ingredient in its formulation.
- Patients with seizure disorders or coagulopathies.
- Patients with abnormal kidney function.
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 |
|---|---|---|
| Alprostadil 5 MCG InjectionDuring the MRI, Alprostadil infusion will be started and titrated to the target dose, ensuring there is a less than 20% drop in blood pressure from baseline. Repeat pressure and MRI flow measurements once Alprostadil reaches 0.1mcg/kg/min. | Drug | Treatment Arm |
Primary outcome
Cerebral blood flow
Time frame: will be measured 30 minutes to 40 minutes after infusion of alprostadil
Cerebral blood flow
Results and safety
The study was stopped early (reason given: Covid 19 and difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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.
Rajiv Chaturvedi, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprostadil 5 MCG Injection in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
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 0 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: stopped early, as of the sponsor's last update on 8 Feb 2023. 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 Canada. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Covid 19 and difficulty with recruitment). Results are not available in the source record.
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?
Cerebral blood flow (time frame: will be measured 30 minutes to 40 minutes after infusion of alprostadil). 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 8 Feb 2023.