Pulmonary Vein StenosisPhase 1/2NCT02769130
Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis
A Phase 1/2 study testing Losartan in people with Pulmonary Vein Stenosis and Children, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis. It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pulmonary Vein Stenosis, Children
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to May 2021
- Phase
- Phase 1/2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stenosis involving 2 or more pulmonary veins
- Consent of parent/legal guardian or child(when appropriate)
Who cannot join
- History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors
- corrected gestational age of less than 40 weeks
- severe renal dysfunction
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.
It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Outcomes include measures of safety/adverse events and progression of pulmonary vein stenosis.
Read the detailed description
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.
Large animal studies have demonstrated that losartan can ameliorate the progression of pulmonary vein stenosis in a surgical model of pulmonary vein stenosis.
There is no safety data for losartan in children < 6months of age or in children with pulmonary vein stenosis. Therefore, this study will test the safety and feasibility of losartan in children in an open label single arm interventional study.
Patient inclusion criteria includes stenosis involving 2 or more pulmonary veins. Patients who are consented into the trial with be on losartan therapy for one year. They will undergo study visits every 3 months. Patients will be screened for adverse events through biochemical tests, routine clinical tests and questionnaires.
An exploratory efficacy analysis will compare progression of pulmonary vein stenosis in children enrolled in losartan to a contemporary cohort of children with pulmonary vein stenosis, who did not receive losartan.
- Conditions
- Pulmonary Vein Stenosis, Children
- Being tested
- Losartan
- Medical subject headings
- Stenosis, Pulmonary Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
Losartan is given for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Losartan will be given to children with stenosis in greater or equal to 2 pulmonary veins.
Maintenance daily dosing is 1mg/kg/day using suspension or tablet formulation of losartan. Losartan will be given for 1 year. Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety:Number of participants with adverse events
adverse events include hypotension, hyperkalemia, renal dysfunction
Measured: 12 months
Feasibility:Number of participants eligible and recruited
includes patient recruitment and compliance with protocol
Measured: 12 months
Secondary outcomes (1)
Progression of pulmonary vein stenosis: survival
Progression of pulmonary vein stenosis measures include survival, morbidity and evidence of progression on clinical tests
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporary suspension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vein StenosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Caldarone, The Hospital for Sick Children
- Investigators
- Christopher A Caldarone, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769130
- Sponsor's protocol ID
- 1000051475
- Status last verified
- Jul 2019
- First submitted
- 9 May 2016
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02769130
- Acronym / sponsor ID
- 1000051475
- Conditions
- Pulmonary Vein Stenosis, Children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporary suspension
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 11 May 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.
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.
It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Outcomes include measures of safety/adverse events and progression of pulmonary vein stenosis.
Detailed description
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.
Large animal studies have demonstrated that losartan can ameliorate the progression of pulmonary vein stenosis in a surgical model of pulmonary vein stenosis.
There is no safety data for losartan in children < 6months of age or in children with pulmonary vein stenosis. Therefore, this study will test the safety and feasibility of losartan in children in an open label single arm interventional study.
Patient inclusion criteria includes stenosis involving 2 or more pulmonary veins. Patients who are consented into the trial with be on losartan therapy for one year. They will undergo study visits every 3 months. Patients will be screened for adverse events through biochemical tests, routine clinical tests and questionnaires.
An exploratory efficacy analysis will compare progression of pulmonary vein stenosis in children enrolled in losartan to a contemporary cohort of children with pulmonary vein stenosis, who did not receive losartan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: LosartanLosartan will be given to children with stenosis in greater or equal to 2 pulmonary veins. Maintenance daily dosing is 1mg/kg/day using suspension or tablet formulation of losartan. Losartan will be given for 1 year. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Stenosis involving 2 or more pulmonary veins
- Consent of parent/legal guardian or child(when appropriate)
Key exclusion criteria (4 listed)
- History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors
- corrected gestational age of less than 40 weeks
- severe renal dysfunction
- pregnancy
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 |
|---|---|---|
| LosartanAlso: CozaarLosartan is given for 12 months | Drug | Losartan |
Primary outcome
Safety:Number of participants with adverse events
Time frame: 12 months
adverse events include hypotension, hyperkalemia, renal dysfunction
Feasibility:Number of participants eligible and recruited
Time frame: 12 months
includes patient recruitment and compliance with protocol
1 secondary outcome
Progression of pulmonary vein stenosis: survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Christopher A Caldarone, 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 1/2 study testing Losartan in people with Pulmonary Vein Stenosis and Children, 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 2 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: paused, as of the sponsor's last update on 30 Jul 2019. 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 combined 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.
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?
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?
Safety:Number of participants with adverse events (time frame: 12 months). The study lists 2 primary outcomes in all. 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 30 Jul 2019.